# Copy of Reg_fun_tbl_data

element:
RS01: Legal framework for establishment of a regulatory system, mandate and enforcement power for each function


element:
RS02: Independence of the regulatory authority in decision making


element:
RS07: Advisory  and or experts committees


element:
RS06: Strategic or and detailed Institutional development plan


element:
RS03: Recall system with mechanism to ensure proper disposition/disposal of affected lots

Ac_rec:
There is a system of withdrawal of the drug, is made up of the preparation procedure for the revocation instruction


element:
RS04: Total quality management system for all the relevant regulatory functions


element:
RS05: Transparency and public accountability


element:
MA07: Requirements for variations to be submitted and assessed


element:
MA06: GMP assessment during marketing authorization process


element:
MA05: Assessment of Quality, Safety and Efficacy (Q,S,E)


element:
MA04: Submission of Marketing authorization and manufacturing license applications


element:
MA02: Quality Management System for marketing authorization and licensing activities


element:
MA08: Clear and comprehensive information on authorized products


element:
MA01: System for marketing authorization and licensing for manufacturing activities


element:
MA09: Same criteria/standards for evaluation of marketing authorization applications for products regardless of the source


element:
PV02: Quality Management System for pharmacovigilance activities


element:
PV06: Regulatory action regarding vaccine performance


element:
PV01: Institutional regulations and Guidelines for the monitoring and management of adverse events following immunization (AEFI)


element:
PV05: Capacity  to detect and investigate significant vaccine safety issues


element:
PV07: Communication system is in place to periodically inform stakeholders about AEFI information.


element:
PV04: Routine and functional system for regular review of safety and efficacy of the vaccine product for regulatory action


# countries

Country/Teritorrie Name:
The former Yugoslav Republic of Macedonia


Country/Teritorrie Name:
Commonwealth of Northern Mariana Islands


# country_vacsource_tbl

Country f:
The former Yugoslav Republic of Macedonia


# CSubject

SubjectName:
Advanced Regulatory Inspection for Vaccines and Biologicals


SubjectName:
WHO-PDA Pharmaceutical Cold Chain Management on Wheels


SubjectName:
NRA planning Meeting/Workshop to strengthen National Regulatory Authorities/ NRA planning workshop to strengthen the vaccine regulatory system/NRA tools meeting


SubjectName:
Design and Development of Training Course Material


# function

Functionns:
1-Marketing authorization (MA) and Activity licensing


Functionns:
2-Post-marketing activities (including surveillance of AEFIs)


Functionns:
2-Post-marketing activities including surveillance of Adverse Events Following Immunization (AEFI)


Functionns:
2- Field surveillance of vaccine results


Functionns:
6- Clinical evaluation of safety and efficiency


Functionns:
1- REGISTRATION OF  PRODUCT & LICENSING OF FACILITIES


Functionns:
2- POST-MARKETING ACTIVITIES INCLUDING AEFI SURVEILLANCE


Functionns:
6- OVERSIGHT OF CLINICAL TRIALS (FOR EVALUATION OF SAFETY & EFFICACY)


Functionns:
1. Autorisation de mise sur le marché et activities d’homologation


Functionns:
2. Surveillance post-commercialisation y compris la surveillance des manifestations  postvaccinales indesirables (MAPI)


Functionns:
3. Mise en circulation des lots par l’ANR


Functionns:
6. Autorisation/approbation des essais cliniques


HLP:
Objective:
The assessor should get a ggeneral understanding of the legislative basis and legal terminology and overview on the National Regulatory System. The assessor should identify all the institutions, autonomous bodies, professional bodies, regulatory bodies, health institutions and any third party involved in the definition, implementation, compliance, enforcement and prosecution related to the regulation on medicinal products/vaccines. The level of intervention such as central level (Ministry of Health (MoH), National Regulatory Authorities), state/province (Regional Regulatory Authority), district or community level (Local Authority) should be identified for each institution.

The assessor should be able to understand for each regulatory function which institutions are responsible for what categories of regulated products. This kind of mapping can be presented in an overall organization chart or under a matrix as follows.
Function	Drugs	Vaccines
Marketing Authorization and licensing activities 
License holder (manufacturers, importers, wholesalers)		
Post-marketing activities including surveillance of AEFI
Safety monitoring of marketed products, AEFI, recalls)		
NRA lot release (official authority batch release)	Not applicable	
Laboratory access (quality control laboratory testing)		
Regulatory inspections 		
Authorization and supervision of  clinical trials		
Control of vaccines or drug promotion		Not applicable
Oversight of distribution channels, storage, cold chain, wholesalers including pharmacists		Mainly done by immunization programme

At this stage, the assessor should begin to identify which organization is in charge of the coordination of all the institutions involved and understand by what means the regulated activities are being coordinated.
To clearly identify all functions, indicators and sub-indicators the following abbreviations are used:
RS: 	National Regulatory System
MA: 	Marketing Authorization and Licensing Activities
PM: 	Post Marketing Activities including Surveillance of Adverse Events following Immunization (AEFI)
LR: 	NRA Lot Release
LA: 	Laboratory Access
RI: 	Regulatory Inspections
CT: 	Regulatory Oversight of Clinical Trials


Functionns:
Function 1: Marketing authorization and licensing activities

HLP:
The marketing authorization (MA) of medicinal products including vaccines and the licensing of the manufacturers are key elements to assure the required safety, quality and efficacy of products to be brought to the county market.
Of similar importance is the control of importers, exporters, wholesalers or any other institution engaged in handling or delivering vaccines.
There is a general problem because only manufacturing is included, but not import, export, wholesaling etc. It may also be better to separate ‘product authorization’ and ‘establishment licenses’ in separate functions. A new indicator MA1b is added (proposal).


Functionns:
Function 2: Post-marketing activities including surveillance of adverse events following immunization (AEFI)

HLP:
Objective:
Post-marketing activities of the NRA are of outstanding importance to guarantee that safe and effective vaccines of high quality are sold and distributed within the country. Programs of post-marketing control activities should be established in the countries based on a risk management approach. Reality shows also that the problems of counterfeited products is increasing and may harm the health of the patients.
A reporting system should be established to monitor vaccines safety. One important activity within that function is to monitoring and assessing AEFI (adverse events following immunization). While common side effects are likely to be detected during the clinical trials (phases I/III), rare events are more likely to occur after the marketing of vaccine products (phase IV). Other unexpected events may also be due to errors and can occur in any stage of the vaccination program. AEFI can occur at any stage during an immunisation programme and can differ with respect to severity, causes and public health consequences. AEFI often lead to public concern and could generate a lack of confidence in vaccination. This may have serious implications for public health with a potential impact on vaccine coverage if it is not dealt with adequately. Post-marketing surveillance of vaccine products is therefore essential.
Networking with other international bodies and NRAs is a logical method for acquiring, sharing, and exchanging the relevant information on vaccines safety and for basing a decision on which to take the appropriate action.


HLP:
Objective:
The unique system of lot release used for vaccines shall guarantee the consistent quality and safety of all vaccine lots. Vaccines contain an inherent risk due to the biological origin of the products, the production procedures and the test systems.


HLP:
Objective:
Vaccines quality control laboratories are responsible for testing, by appropriate testing methods, whether vaccines are of the required quality. In principle each NRA should have access to a quality control laboratory, which will also play an important role in the registration process, lot release and in the surveillance of the quality of marketed products.


HLP:
Objective:
The function is intended to ensure that all activities in vaccine manufacturing, import, export, distribution, etc. comply with the regulatory and quality requirements


Functionns:
Function 6: Regulatory oversight of clinical trials

HLP:
Objective:
The function is intended to assess if organization is set in place in the country to control the clinical trials (CT) and to review how national regulatory authority (NRA) performs the regulatory oversight of CT.


Functionns:
Fonction 1: Autorisation de Mise sur le Marché (AMM) et Activités d'homologation


Functionns:
Fonction 2: Surveillance Post-commercialisation y compris la surveillance des Manifestations Post-vaccinales Indésirables (MAPI)


Functionns:
Fonction 3: Mise en circulation des lots par l'ANR


Functionns:
Fonction 6: Surveillance réglementaire des essais cliniques


Functionns:
Function 1: Marketing Authorization and Licensing activities

HLP:
The marketing authorization (MA) of medicinal products including vaccines and the licensing of
the manufacturers are key elements to assure the required safety, quality and efficacy of products
to be brought to the county market.


Functionns:
Function 2: Post-marketing activities including surveillance of Adverse Events Following Immunization (AEFI)

HLP:
Objective:
Post-marketing activities of the NRA are of outstanding importance to guarantee that safe and
effective vaccines of high quality are used within the country. Programs of post-marketing control
activities should be established in the countries based on a risk management approach. Reality
shows also that the problems of counterfeited products is increasing and may harm the health of the
patients.
A reporting system should be established to monitor vaccines safety. One important activity within
that function is to monitoring and assessing AEFI (adverse events following immunization). While
common side effects are likely to be detected during the clinical trials (phases I/III), rare events are
more likely to occur after the marketing of vaccine products (phase IV). Other unexpected events
may also be due to errors and can occur at any stage of the vaccination program. AEFI can occur at
any time during an immunisation programme and can differ with respect to severity, causes and
public health consequences. AEFI often lead to public concern and could generate a lack of
confidence in vaccination. This may have serious implications for public health with a potential
impact on vaccine coverage if it is not dealt with adequately. Post-marketing surveillance of
vaccine products is therefore essential.
Networking with other international bodies and NRAs is a logical method for acquiring, sharing,
and exchanging the relevant information on vaccines safety and for basing a decision on which to
take the appropriate action.


HLP:
Objective:
The function is intended to ensure that vaccines are subject to scrutiny by national regulatory
authorities on a lot-by-lot basis as they contain an inherent risk due to the biological origin of the
products,
The initial review of vaccine lots is performed during the licensing process when the methods of
manufacture and testing, and the consistency of production of several lots are evaluated. Once
licensed, vaccines are released lot by lot by the NRA, based as a minimum on a review of the
summary lot protocol of the manufacturing steps and test results from the full manufacturing and
control process, not just the final product QC release.


HLP:
Objective:
The function is intended to ensure the National Regulatory Authority is able to assess the quality of
vaccines by performing tests on products in certain situations. In order to do this, the National
Regulatory Authority must have access to suitable laboratories where these tests can be performed.
A well-functioning laboratory for vaccines testing is an important resource for the national vaccine
regulatory system. The staff with expertise in vaccinology can help in regulatory
decisions such as assessment of marketing authorizations and review of clinical
trial data.


HLP:
Objective:
The function is intended to ensure that all activities in vaccine manufacturing, import, export,
distribution, etc. comply with the regulatory and quality requirements


HLP:
Objective:
The function is intended to assess if organization is set in place in the country to control the clinical
trials (CT) and to review how national regulatory authority (NRA) performs the regulatory
oversight of CT.


Functionns:
Function 1: Marketing Authorization and Licensing Activities


Functionns:
Function 2: Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI)


Functionns:
Fonctions 1: Autorisation de Mise sur le Marché (AMM) et activités d'homologation


Functionns:
Fonctions 2: Activités de pharmacovigilance, y compris la surveillance des Manifestations Adverses Post Immunisation (MAPI)


Functionns:
Fonctions 3: Libération des lots par l'ANR


Functionns:
Fonctions 6: Surveillance réglementaire des essais cliniques


Functionns:
01 MA: MARKETING AUTHORIZATION (MA) FOR MEDICAL DEVICES AND DIAGNOSTICS


Functionns:
02 LI: LICENSING OF MANUFACTURERS, IMPORTERS, DISTRIBUTERS AND RETAILERS OF MEDICAL DEVICES AND DIAGNOSTICS


Functionns:
04 VR: VIGILANCE AND RISK MANAGEMENT ACTIVITIES ON MEDICAL DEVICES AND DIAGNOSTICS


Functionns:
05 PR: CONTROL OF PROMOTION AND ADVERTISEMENT FOR HEALTH PRODUCTS


Functionns:
06 CT: OVERSIGHT OF CLINICAL TRIALS ON IVDS AND MD


Functionns:
07 IE: INSPECTIONS AND ENFORCEMENT ACTIVITIES


Functionns:
01 MA REGISTRATION AND MARKETING AUTHORIZATION (MA) FOR MEDICINAL PRODUCTS


Functionns:
02 LI LICENSING ACTIVITIES FOR MEDICINAL PRODUCTS (LI)


Functionns:
03 RP REGISTRATION OF HEALTH PERSONNEL (RP)


Functionns:
05 PR CONTROL OF PROMOTION AND ADVERTISEMENT (PR)


Functionns:
06 IE INSPECTIONS AND ENFORCEMENT ACTIVITIES (INS)


Functionns:
07 LA LABORATORY ACCESS AND TESTING (LC)


Functionns:
08 NA CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS (NAR)


Functionns:
03. LICENSING AND/OR REGISTRATION OF BLOOD ESTABLISHMENTS


Functionns:
04. LICENSING AND/OR REGISTRATION OF MANUFACTURERS AND DISTRIBUTORS OF PLASMA-DERIVED MEDICINAL PRODUCTS


Functionns:
05. APPROVAL OF BLOOD AND BLOOD COMPONENTS (PRODUCT AND/OR PROCESS APPROVAL)


Functionns:
06. APPROVAL OF PLASMA-DERIVED MEDICINAL PRODUCTS


Functionns:
07. REGULATORY OVERSIGHT OF ASSOCIATED SUBSTANCES AND MEDICAL DEVICES INCLUDING IN VITRO DIAGNOSTICS


Functionns:
08. ACCESS TO A LABORATORY INDEPENDENT OF MANUFACTURERS


Functionns:
10. SYSTEM FOR LOT RELEASE OF PLASMA-DERIVED MEDICINAL PRODUCTS


Functionns:
11. REGULATORY INSPECTIONS AND ENFORCEMENT ACTIVITIES


Functionns:
13. ENSURING TRACEABILITY AND RECORD KEEPING BY MANUFACTURERS FOR ALL REGULATED PRODUCTS


Functionns:
02-MA REGISTRATION AND MARKETING AUTHORIZATION (MA) FOR MEDICINAL PRODUCTS


Functionns:
03-PV LOT RELEASE, IMPORT/EXPORT CONTROL, POST MARKETING AND PHARMACOVIGILANCE SURVEILLANCE (PV)


Functionns:
04-LI LICENSING ACTIVITIES FOR MEDICINAL PRODUCTS (LI)


Functionns:
05-RP REGISTRATION OF HEALTH PERSONNEL (RP)


Functionns:
06-PR CONTROL OF PROMOTION AND ADVERTISEMENT (PR)


Functionns:
07-IE INSPECTIONS AND ENFORCEMENT ACTIVITIES (IE)


Functionns:
08-LA LABORATORY ACCESS AND TESTING (LC)


Functionns:
09-NA CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS (NAR)


Functionns:
MODULE 03 NATIONAL REGULATORY AUTHORITY (NRA):


Functionns:
MODULE 06 LICENSING OF IMPORTERS, EXPORTERS, WHOLESALERS AND DISTRIBUTORS


Functionns:
MODULE 07 LICENSING PHARMACIES AND RETAIL OUTLETS:


Functionns:
MODULE 08 REGISTRATION OF PHARMACY PERSONNEL:


Functionns:
MODULE 09 POST MARKETING SURVEILLANCE AND CONTROLS:


Functionns:
MODULE 10 CONTROL OF DRUG PROMOTION AND ADVERTISING:


Functionns:
MODULE 13 REGULATORY INSPECTIONS AND ENFORCEMENT ACTIVITIES:


Functionns:
MODULE 15 CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS


Functionns:
MODULE 16 INTERNATIONAL COOPERATION AND HARMONISATION:


Functionns:
12-INTERNATIONAL COOPERATION AND HARMONISATION (IC)


Functionns:
Modulo 02. Autoridad reguladora nacional


Functionns:
Modulo 03. Autorización de comercialización


Functionns:
Modulo 04. Actividades de licenciamiento


Functionns:
Modulo 05. Vigilancia y control posteriores a la comercialización


Functionns:
Modulo 08. Inspecciones regulatorias y actividades de fiscalización


Functionns:
Modulo 09. Laboratorio de control de calidad


Functionns:
02-REGISTRATION AND MARKETING AUTHORIZATION (RMA)


Functionns:
07-REGISTRATION OF HEALTH PERSONNEL (RHP)


Functionns:
08-CONTROL OF PROMOTION AND ADVERTISEMENT (CPA)


Functionns:
11-CONTROL OF NARCOTICS, PSYCHOTROPIC AND SUBSTANCES AND PRECURSORS  (NPSP)


Functionns:
05. Post-Marketing Monitoring and Control – Import and Export Controls.


Functionns:
08. Regulatory Inspections and Audit Activities


Functionns:
09. Official Medicines Control Laboratory (OMCL)


Functionns:
10. Batch Release of Biological Products (Vaccines)


Functionns:
04-Market Surveillance and Control (MSC)


Functionns:
MODULE # 3 LICENSING OF MANUFACTURERS, IMPORTERS, DISTRIBUTERS, AND RETAILERS


Functionns:
MODULE # 6 INSPECTIONS AND ENFORCEMENT ACTIVITIES


Functionns:
MODULE # 7 LABORATORY ACCESS AND TESTING


Functionns:
MODULO # 2 REGISTRO (AUTORIZACION DE COMERCIALIZACION)


Functionns:
MODULO # 3 CONCESIÓN DE LICENCIAS A FABRICANTES, IMPORTADORES, DISTRIBUIDORES Y MINORISTAS


Functionns:
MODULO # 4 VIGILANCIA POSTCOMERCIALIZACIÓN


Functionns:
Pharmaceutical Inspection Co-operation Scheme Assessment Tool Summary


Functionns:
01.General information on Member State and assessment


Functionns:
03.National regulatory authority for diagnostics (NRA)


Functionns:
08.Licensing of importers, exporters, wholesalers and distributors of diagnostics


Functionns:
09.Control of diagnostics promotion and advertising


Functionns:
12. National reference laboratory for diagnostics


Functionns:
03. External Cooperation (with competent authorities and suppliers)


Functionns:
04. Maintenance of the Management System


Functionns:
10. Validation of Computerised Systems (5.4.7/OMCL)


Functionns:
Function 02: Assessment of marketing authorization applications


Functionns:
Function 03: Pharmacovigilance (drug safety) activities


Functionns:
10 Management system requirements for certification bodies


Functionns:
The Prevention, Detection and Response to SSFFC medical Products


Functionns:
01 Legislative and Regulatory Requirements and Scope


# ML_TBL

Guidance:
Not met, no ongoing activity exist to document indicator, no legal requirements/mandate to implement it,  and no documentation or and no staff to perform it. None of the objectives assigned to the indicator is achieved.


Guidance:
Not met, some activity exist document partial or limited implementation of indicator, no QMS principles applied to document indicator. Only some objectives assigned to the indicator are achieved or partially achieved.


Guidance:
Met,  routine activities exist to document indicator, principle s of QMS documentation applied and exist to document indicator but not addressing all processes, not all objectives assigned to the indicator are achieved.


Guidance:
Met, routine activities exist and are all documented as per an ISO based QMS, all objectives assigned to the indicator are met and indicator is routinely monitored and audited with internal and external audit and report is available but not published.


Guidance:
Met, routine activities exist and are all documented as per an ISO based QMS, all objectives assigned to the indicator are met and indicator is routinely monitored and audited with internal and external audit and report is available and published.


# P_N_SubInd_tbl

sub_indictor_txt:
PV04.05: Manufacturers are notified of significant safety and efficacy issues and kept up to date or/and at upon request


sub_indictor_txt:
PV02.01: Defined Organizational chart & responsibilities to implement the quality management system


sub_indictor_txt:
PV02.02: Management system to ensure traceability of actions


sub_indictor_txt:
PV05.04: A national database or system for collating, managing and retrieving AEFI reports exists


sub_indictor_txt:
PV06.01: Evidence that appropriate regulatory action consistent with NRA guideline is taken in case of serious AEFI cases


sub_indictor_txt:
PV04.02: Information on serious cases and AEFI clusters and investigation reports shared between NRA, NCL, national immunization program, and disease surveillance and pharmacovigilance staff


sub_indictor_txt:
PV02.03: Auditing system documented & implemented (external & internal)


# Ref_table

Ref:
04.01.02 The legislation empowers the NRA to issue the license, but also to suspend and close/stop production activities.


Ref:
05.01.02 The legislation enables the NRA to issue a licence for a manufacturer of pharmaceutical products
or active pharmaceutical ingredient, to suspend it for a period of time and to withdraw it.


Ref:
07.01.03 The legislation enables the NRA to issue a licence for a pharmacy, a retail outlet or an internet
pharmacy, to suspend it for a period of time and to withdraw it.


Ref:
IE02.01: Documentation for conducting inspections including sanctions and reporting


Ref:
RI04.01: Documentation for conducting inspections


Ref:
RI02.02: Written documentation for performing activities


Ref:
08.05.07 There are procedures/tools to verify compliance with GMP, GDP, GCP, GLP, Good Monitoring Practice and Good Dispensing Practice.


Ref:
08.05.20 There are time limits for filing and delivery of inspection reports.


Ref:
13.05.19 An internal tracking system is established to follow the targeted time frames (statutory or not).


Ref:
13.05.05 Documented procedures/tools are implemented to perform the inspections and in particular on
assessing the critical steps of the processes and validation.


Ref:
08.05.06 There are procedures/tools to develop GMP inspections, and in particular on the evaluation of critical steps of the processes and validation.


Ref:
13.05.06 Documented procedures/tools are implemented to check compliance with the GMP, GDP, GCP,
GLP, Good vigilance practices and good dispensing practices.


Ref:
08.05.12 Observations of noncompliance are classified/categorized according to risk (critical, major and minor).


Ref:
13.05.09 The observations of non compliance are classified/categorized according to the risk (critical, major
and minor).


Ref:
05.04.10 The same criteria are used for licensing regardless of the affiliation (e.g. domestic, foreign, public,
private sector, NGO) of the manufacturer concerned.


Ref:
06.04.09 The same criteria are used for licensing regardless of the affiliation (e.g. domestic, NGO, foreign,
public, private sector) of the applicant concerned.


Ref:
04.05.11 The same GMP standard is used for licensing, regardless of the source (e.g., domestic, foreign, public or private sector) in production.


Ref:
LI07.03: An inspection visit is required for granting a license or a substantial modification.


Ref:
08.09.03 The data of the last inspection are publicly available.


Ref:
13.08.03 A summary of the inspection reports are published and are publicly available, following applicable
local confidentiality requirements.


Ref:
IE06.02 Information on inspections performed  provided to the public and health professionals


Ref:
08.05.04 The internal planning for the inspection activities is established and updated to cover all regulation activities.


Ref:
13.05.03 The internal planning for inspection activities is established and updated to cover all regulated
activities.


Ref:
08.05.03 There are procedures/tools for planning inspection activities indicating in particular the duration and frequency of inspections.


Ref:
IE02.03: Plan for inspections at appropriate intervals and based on quality risk management exists


Ref:
13.05.02 Documented procedures/tools are implemented for the planning of inspection activities showing in
particular the duration and frequency of the inspections.


Ref:
RI04.02: Plan for inspections at appropriate intervals and based on quality risk management exists


Ref:
08.07.11 Producers or representatives of the license holders are never invited to conduct inspections.


Ref:
IE06.01: Management of conflict of interest and confidentiality provisions is established


Ref:
13.06.08 Manufacturer's or licence holder's representatives are never used to conduct inspections.


Ref:
RI04.05: Management of conflict of interest and confidentiality provisions  is established


Ref:
RI04.04: Use of team approach to ensure expertise in specific products


Ref:
IE03.02: Use of team approach to ensure expertise in specific products


Ref:
08.05.19 The same approach is used to perform domestic, foreign, public or private inspections.


Ref:
IE03.01: The same criteria are used for the inspection despite of the location and type of facilities/sites (domestic, foreign, public, private, profit and non for profit)


Ref:
13.05.17 The same criteria are used for the inspection of domestic, foreign, public and private facilities.


Ref:
07.01.05 The legal provisions require the notification of the NRA of significant changes/variations to the
initial license.


Ref:
04.01.04 Legal provisions require notification from the manufacturer to the NRA for approval of changes/significant variations to the conditions under which the initial license was issued that may affect the quality, safety and efficacy of the products.


Ref:
05.01.04 The legal provisions require notification of the NRA of significant changes/variations to the initial
licensing conditions.


Ref:
08.05.16 There are procedures for decision-making.


Ref:
RI05.01: Evidence that the follow up process is documented and implemented


Ref:
13.05.13 Documented procedures are implemented for decision-making.


Ref:
RI05.02: Evidence that regulatory action is taken in case of non-compliance


Ref:
08.05.17 There are procedures to monitor deficiencies/violations requiring compliance (including deadlines) and to issue warnings about them.


Ref:
IE02.05: A documented procedure is implemented to issue good practice related certificates in a standardized format, based on the evidence provided by inspection activities.


Ref:
IE04.02: Evidence that the follow up process is documented and implemented and regulatory action is taken in case of non-compliance


Ref:
13.05.15 Documented procedures are implemented on investigation activities, any seizure or prosecution.


Ref:
13.05.14 Documented procedures are implemented for follow-ups on deficiencies/violations to enforce
compliance (including timeframes) and to issue notices on the violations.


Ref:
IE02.04: Documented procedures are implemented for decision-making taking into consideration the results obtained at all the steps of the process as well as the plan of actions developed by inspectors..


Ref:
08.02.02 There is a deadline for compliance with GMP, GCP, GLP and GDP in all national facilities (in case legal provisions have recently been adopted).


Ref:
RI06.02: National GDP code equivalent with WHO GDP (in TRS 937 [18] or any update) and published


Ref:
08.02.04 The national GMP code is published and is equivalent to the WHO GMP (TRS 902 11, TRS 908, TRS 822 or any update) or some other recognized standard.


Ref:
13.02.05 There are guidelines for the environmentally-conscious disposal of expired/unusable substances,
reagents and finished products.


Ref:
08.02.01 There is a document that describes the criteria for the application of sanctions according to the nature of the violation.


Ref:
08.06.02 The National Code of Good Distribution Practice must be equivalent to that of the WHO (TRS 9377 or any update) and must be published.


Ref:
13.02.04 There are guidelines for conducting pre- and post- licensing inspections.


Ref:
13.02.03 There is a deadline for GMP, GCP, GLP and GDP compliance for all domestic facilities (in case of
recently adopted legal provisions).


Ref:
RI01.01: National GMP code at least equivalent with WHO GMP (TRS 902[11] , TRS 908[16], TRS 822[17] or any update)


Ref:
08.02.03 There are guidelines for conducting pre- and post-licensing inspections.


Ref:
IE01.05: Good practices code equivqlent with WHO or other internationaly recognized guidelines


Ref:
13.02.01 There is a guidance on the compliance and enforcement strategy taken by the NRA defining the
pyramid of sanctions applicable.


Ref:
RI03.02: Staff training plan developed and implemented


Ref:
08.07.05 Developed and implemented staff training plan.


Ref:
08.07.03 The expertise required to be appointed as external or internal expert is defined on the basis of education, experience and training.


Ref:
13.06.07 The inspectors are trained on the specific areas (GMP, GDP, GCP, GLP).following a training
program. The training activities are recorded and such records are kept up-to-date.


Ref:
08.07.10 Inspectors are trained in specific areas (GMP, GDP, GCP, GLP) according to a training program. Training activities are recorded and such records are updated.


Ref:
RI01.06: Provision or written criteria for recognition of other Inspectorates (NRAs) GMP Certificates, reports and or decisions


Ref:
08.02.05 Provisions (or written criteria) for the recognition of certificates/reports/decisions of other NRAs (if appropriate)


Ref:
IE02.02: Documented procedures/tools are implemented for checking compliance with Good Practices (GXP)


Ref:
13.05.01 The inspectorate establishes compliance monitoring programs based on activities that are
supervised (GMP, GDP, GCP, Pharmacy, Retail outlets, etc…).


Ref:
08.05.01 Inspections are established according to a monitoring program based on activities that will be evaluated (GMP, GDP, GCP, pharmacies, distributors, etc.).


Ref:
13.05.20 A documented procedure is implemented to issue Good Practices related certificates in a
standardized format.


Ref:
IE03.03: NRA to ensure that an equivalent system is in place to ensure manufacturer GMP compliance prior to marketing authorization


Ref:
RI01.02: NRA to ensure that an equivalent system is in place to ensure manufacturer GMP compliance prior to marketing autorization


Ref:
IE04.01: Good Practices certificate as well as any other regulatory decision is established and published for each facility and/or premises signed by a staff of the NRA, with the delegation of the requisite authority are sent to the interested party.


Ref:
04.08.02 The list/database of all licenses of producers: withdrawn, suspended or rejected is public and publicly available.


Ref:
05.07.01 The list/data base of all the licensed manufacturers is published.


Ref:
05.07.02 The list/data base of all the licenses withdrawn, suspended or refused for manufacturers is
published and is publicly available.


Ref:
07.07.01 The list/data base of all the licensed pharmacies and retail outlets is published and is publicly
available.


Ref:
04.08.01 The list/database of all licensed producers is published and publicly available.


Ref:
LI11.01: All publicly available information is kept up-to-date


Ref:
LI10.01: Information on licenced sites and authorized companies is publicly available


Ref:
07.07.02 The list/data base of all the licenses for pharmacies and retail outlets withdrawn, suspended or
refused is published and is publicly available.


Ref:
LI08.01: Assessment report prepared and used as reference for decision


Ref:
04.05.07 The license is issued in a standardized form (following a procedure or other document to ensure consistency in content and form).


Ref:
05.04.13 A written license, signed by a person with the adequate delegation, is sent to the applicant,
including conditions or restrictions attached to the licence (validity and renewal).


Ref:
04.05.15 It is established that updates of facilities and product are provided by the producers to the NRA to keep the information updated and in accordance with the terms of the license.


Ref:
08.01.06 Authority to have access to any production site and documents that are relevant for inspection.


Ref:
RI01.04: Authority to access any premises and documents that are relevant for the inspection


Ref:
IE01.04: The legal provisions allow announced or unannounced inspections.


Ref:
08.07.12 The list of inspectors who are qualified in their respective areas of expertise is available and kept current.


Ref:
08.08.01 There is a list/updated database of all facilities inspected.


Ref:
08.09.02 The updated list/database of all inspected facilities is public and publicly available.


Ref:
13.07.01 There is a list/data base of all inspected facilities.


Ref:
13.08.02 The list/data base of all the inspected facilities is published and is publicly available.


Ref:
13.06.05 There is a documented process on qualification and review to confirm the competencies required
for being inspectors.


Ref:
RI03.03: Monitoring acquired skills and or competencies of the staff after training


Ref:
08.07.09 There is a procedure to qualify, monitor and/or confirm the required expertise for beginner inspectors.


Ref:
08.07.06 Skill development monitoring subsequent to training activities.


Ref:
IE08.02 The competency of staff is assessed and monitored at established intervals and following trainings


Ref:
08.07.14 Adequate support services are provided in terms of transport and communication.


Ref:
08.07.13 There is a suitable office and storage space for the activities of the inspectors.


Ref:
13.06.11 The equipment is adequate and well maintained for regulatory activities.


Ref:
13.06.10 There is adequate office and storage space for the inspectorate’s activities.


Ref:
13.06.12 Adequate support services are provided in terms of transport and communication.


Ref:
13.05.16 Documented procedures are implemented to ensure the adequate involvement and
communication between the inspectors, QC laboratory staff and licensing or registration staff.


Ref:
08.05.18 There are internal procedures or mechanisms to ensure proper integration and communication among inspectors, QC laboratories and licensing or registration staff.


Ref:
13.08.04 The information regarding the enforcement activities such as notices of compliance, penalties,
prosecutions engaged are published and are publicly available.


Ref:
08.09.04 Updated information relating to audit activities, such as conformity warnings, fines, prosecutions, etc. are public and publicly available.


Ref:
RI03.01: Adequately qualified staff (education, training, skills and experience) to perform inspections and related activities


Ref:
IE08.01 Adequately qualified staff (education, training, skills and experience) to perform inspections and related activities


Ref:
08.07.07 The minimum qualification, experience and training to develop all types of inspections are defined.


Ref:
08.07.04 Duly qualified staff (studies, training, skills and experience) to carry out inspections and related activities.


Ref:
13.06.03 The minimum qualification, experience and training for performing all kinds of inspections is
defined.


Ref:
13.06.02 There is enough personnel (internal and external) with adequate expertise (education, experience
and training) for the inspection of all pharmaceutical products and regulated activities such as:


Ref:
13.05.10 Documented quality control measures are in place such as peer-review.


Ref:
13.06.09 The list of inspectors that are qualified with their specific areas of competencies is available and is
kept up-to-date.


Ref:
13.08.01 The list and identity of the designated inspectors is available to the companies subjected to
inspection.


Ref:
IE04.03: There is an updated list/database of all inspected facilities and reports of inspections available for all types of inspections


Ref:
13.01.01 There is a legal provision to inspect premises where regulated activities are performed in order to
check compliance with the applicable regulation, good practices and standards.


Ref:
13.01.05 The inspectors have adequate powers and authority to carry on their missions.


Ref:
RI06.01: Provision for monitoring onward distribution as appropriate


Ref:
13.01.04 There is a legal provision designating the inspectors and their powers.


Ref:
08.06.01 Provision for subsequent monitoring of the distribution, as appropriate.


Ref:
08.06.03 Only authorized products are distributed.


Ref:
13.01.03 There is a legal provision allowing the inspection of foreign sites of manufacturers.


Ref:
13.01.02 There is a legal provision specifying the periodicity for regulatory inspections.


Ref:
RI06.03: Only authorized products are distributed


Ref:
13.01.07 The legislation provides for adequate and proportional sanctions, penalties and prosecution upon
conviction based on violation of the applicable legislation.


Ref:
RI01.05: Enforcement power to suspend or stop production in any vaccine manufacturing facility in the country


Ref:
08.01.03 There is a legal provision that allows for the inspection of plants/sites or foreign producers.


Ref:
08.01.02 There is a legal provision that specifies the frequency of inspections for compliance with the regulation.


Ref:
08.01.01 There are legal provisions to inspect facilities to verify compliance with regulations, standards and good practice.


Ref:
08.01.04 There is a legal provision for the appointment of inspectors and their powers.


Ref:
08.01.05 Inspectors have appropriate powers and authority.


Ref:
08.01.08 The legislation provides appropriate and proportionate sanctions, fines and criminal prosecution in case of conviction of violations of current law.


Ref:
IE01.02: Enforcement power to take implement regulatory decisions in any licenced site or activity


Ref:
IE01.01: Legal provision for performing inspections and enforcement activities


Ref:
07.01.02 There is a legal provision for licensing internet pharmacy or retailers.


Ref:
LI01.01: Legal provision exist for licensing of sites/facilities


Ref:
04.01.01 The legislation requires that a company that produces or plans to produce a drug and vaccines must hold a license or GMP certificate to confirm that the establishment complies with GMP as recommended by the World Health Organization, according to


Ref:
04.01.03 Legal provisions require producers to comply with GMP to request licensing.


Ref:
04.01.05 There are legal provisions that require at least one qualified person responsible for each production site.


Ref:
05.01.06 There are legal provisions requiring at least one qualified responsible person for each
manufacturing premises.


Ref:
05.01.03 The legal provisions require the manufacturers to comply with the applicable good manufacturing
practices. Compliance with applicable GMP is a condition for keeping its license.


Ref:
05.01.01 The legislation requires a company which manufactures or intends to manufacture a
pharmaceutical product or an active pharmaceutical ingredient to hold a licence.


Ref:
LI01.02: License to manufacture granted on the basis of demonstrated compliance with Good practices (GXP)


Ref:
07.01.01 The legislation requires that pharmacies and retail outlets or prospective pharmacies and retail
outlets of pharmaceutical products to hold a licence.


Ref:
RI04.03: Reports of inspections available for all types of GMP inspections


Ref:
13.05.08 There is a standard format for reporting inspection gaps or deficiencies such as an inspection
report.


Ref:
08.05.10 A standard form is defined for reporting deficiencies.


Ref:
06.04.10 There are timelines for the assessment of the applications.


Ref:
04.05.12 There are clear timetables for the evaluation of new applications, renewals and modifications of licenses, as appropriate.


Ref:
05.04.11 There are defined timelines for the assessment of applications.


Ref:
RI01.03: Mandate to inspect and collect samples at any vaccine manufacturing facility in the country


Ref:
IE01.03: Empowerment and mandate to inspect and collect samples at any health product manufacturing sites in the country


Ref:
08.06.04 Mandate to inspect and collect samples at any point in the vaccine distribution chain in the country.


Ref:
RI06.04: Mandate to inspect and to collect samples at any point of the distribution chain of vaccines in the country


Ref:
08.01.09 Power to inspect and take samples at any establishment in the country that produces drugs and biological products.


Ref:
04.02.04 There are guides for applicants on the definition of the types and purposes of the changes, form and required documentation.


Ref:
07.02.03 There are guidelines for applicants on the definition of the types and scopes of variations and the
documentation required.


Ref:
04.02.02 There are guides for producers on the content of the application, form and procedure to follow for submitting a license protection application as appropriate.


Ref:
05.02.04 There are guidelines for applicants on the definition of types and scopes of variations and the
documentation required.


Ref:
07.02.01 There are guidelines for pharmacies and retail outlets on the content of the application, the format
and the procedure to follow when applying for a licence.


Ref:
LI03.03: Written guidelines for applicants with definition of types and scopes of variations and documentation required


Ref:
05.02.02 There are guidelines for manufacturers on the content of the application, the format and the
procedure to follow in order to submit an application for a manufacturing license.


Ref:
CT02.03: Mandate and enforcement power for NRA to inspect, suspend or/and stop CT is defined and documented


Ref:
12.01.01 There is a legal provision for the authorization, suspension and withdrawal of clinical trials by the
NRA or by another delegated authority for pharmaceutical products.


Ref:
CT01.03: Mandate and enforcement power for NRA to inspect, suspend or/and stop CT is defined and documented


Ref:
03.05.02 The NRA maintains a file for each registered product as well as modifications and renewals with support documentation, including application, approved drug information, evaluation report, risk/benefit evaluation, etc. and all exemptions are docum


Ref:
04.06.02 The NRA retains a master file of each product licensed or application refused as well as of all the variations and renewals with the supporting documentation including the application,


Ref:
CT01.02: Roles and responsibilities of all stakeholders/institutions involved in CTs are defined


Ref:
07.01.05 The legal bases (laws, decrees, resolutions, regulations or other) require research centers, researchers, sponsors, CROs and everyone involved in the clinical trial to comply with Good Clinical Practice.


Ref:
CT01.01: Provision for regulation of clinical trials consistent with WHO Good Clinical Practices guideline (GCP) or other international accepted guidance, exists.


Ref:
12.01.08 There are legal provisions on specific labelling and packaging requirements for the investigational
products.


Ref:
12.01.05 The legal provisions require the investigational/research centres to comply with Good Clinical
Practices and Good Laboratory Practices.


Ref:
04.01.08 The legal provisions envisage the case of provisional or conditional MA exempting applicants from
meeting specific requirements based on the established criteria (orphan drug, public health
interest, presumed positive benefit/risk balance).


Ref:
04.01.09 There is an exemption for pharmaceutical product donations following the established criteria.


Ref:
03.01.11 The regulations provide for the cases of conditional or provisional HR exempting from specific requirements based on established criteria (for example, orphan drugs, public health interest, presumed positive risk/benefit balance).


Ref:
03.01.12 An exemption from health registration is provided for donated drugs, following established criteria.


Ref:
MA09.02: Written criteria to cover circumstances in which the routine licensing procedures may not have to be followed


Ref:
MA01.14: Written criteria to cover circumstances in which the routine licensing procedures (i.e. Orphan device, public health interest) may not be followed


Ref:
04.05.01 The job descriptions for the following staff are defined: head of registration (supervisor), head of
registration unit by products and assessors with their areas of assessment


Ref:
03.04.04 The skills developed after the training activities are monitored.


Ref:
03.04.01 The job descriptions are defined for the following staff members: head of registration (supervisor), head of the registration unit by type of products and advisors with their evaluation areas (bioequivalence, chemical, clinical, microbiological,


Ref:
MA03.02: Staff training plan developed and implemented


Ref:
MA03.03:  Monitoring acquired skills and or competencies of the staff after training


Ref:
MA03.01: Adequate qualified staff (number, education, training, skills and experience) to perform MA activities


Ref:
04.05.02 There is enough personnel (internal and external) with the adequate expertise (education,
experience and training) for the assessment of the different parts of the application for all types of
authorized pharmaceutical products.


Ref:
04.05.03 There is internal planning of human resource utilisation for performing any upcoming and
periodical reviews of the applications.


Ref:
03.04.03 There is internal planning of human resources for development and updating, and it is periodically reviewed.


Ref:
03.04.02 There is adequate internal and external expertise (education, experience and training) for the evaluation of the different parts of the application for HR.


Ref:
MA06.02: Documented procedures are implemented to ensure involvement, cooperation and communication between the assessment organization, the quality control laboratory for product compliance and the inspectorate for compliance to applicable good practices


Ref:
03.03.20 There is a procedure to ensure participation and communication between the evaluators of the registration application and the staff of the quality control laboratory concerning the compliance of the product and/or regular inspections to ensure co


Ref:
04.04.20 Documented procedures are implemented to ensure the involvement and communication between
the assessors and the QC laboratory for product compliance and the regulatory inspectorate for
compliance to applicable good practices.


Ref:
04.01.03 There are legal provisions requiring the applicants to demonstrate the quality, safety and efficacy
of the pharmaceutical product that is subject of the application.


Ref:
MA01.06: Legal provisions require the applicants to demonstrate the quality, safety and efficacy of the pharmaceutical product subject to an application for marketing authorization.


Ref:
03.01.04 There are regulations to require applicants to demonstrate the quality, safety and efficacy of drugs subject to health registration application.


Ref:
07.01.04 The legal bases (laws, decrees, resolutions, regulations or other) require notification to the NRA on changes/variations (amendments) in the original protocol of the CT.


Ref:
07.01.01 There is a legal basis (laws, decrees, resolutions, regulations or other) for authorization of clinical trials as well as their suspension by the NRA or another delegated authority.


Ref:
CT03.02: Staff training plan developed and implemented


Ref:
03.02.07 There are guidelines for applicants defining the types and objectives of the changes, format and required documentation and specifying that the changes are subject to prior approval.


Ref:
04.02.08 There are guidelines for marketing authorization holders defining the types and scopes of
variations, the format and the documentation required as well as specifications of the variations
that are subjected to prior approval.


Ref:
MA02.06: Written criteria/guidelines for applicant with definition of types and the scopes of variation and documentation required.


Ref:
MA07.01: Written guidelines for applicants with definition of types and scopes of variations and documentation required


Ref:
03.04.06 There are lines of authority that reflect the independence in decision-making in the health registration system in relation to producers, suppliers or government.


Ref:
04.05.05 There are lines of authority reflecting the independence of decision-making in the MAs system
from manufacturers, supply systems or government.


Ref:
MA06.06: NRA to ensure that an equivalent system is in place to ensure manufacturer GMP compliance prior to marketing authorization


Ref:
MA06.02:GMP assessment for nondomestic manufacturers
a.Agreement with other NRA for exchange of inspection reports/GMP certificates or list of reference countries/agencies that certificates and decisions are accepted or
b.Foreign country Inspection


Ref:
MA06.01: GMP assessment for domestic manufacturers through dedicated inspections on the manufacture site


Ref:
04.02.06 There are guidelines on the applicable requirements to the demonstrate
bioequivalence/bioavailability.


Ref:
04.02.05 There are guidelines on the applicable requirements on stability testing of pharmaceutical
products (API, finished products).


Ref:
04.02.04 There are guidelines on the applicable requirements on analytical method validation.


Ref:
03.02.03 There are guidelines for the application of HR in terms of requirements on validation of analytical methods.


Ref:
03.02.04 There are guidelines for the application of HR in terms of stability requirements.


Ref:
04.02.03 There are guidelines on the applicable requirements on various process validation (manufacturing,
IT, etc…).


Ref:
CT01.07: Feedback report from sponsors or contract research organizations (CROs) during and after clinical trials are available or and send sent to NRAs /ethic Committee


Ref:
CT02.07: Feedback report from sponsors or contract research organizations (CROs) during and after clinical trials are available or and send sent to NRAs /ethic Committee


Ref:
CT05.02: Preclinical data submitted for Investigational Pharmaceutical Products


Ref:
07.01.14 There are legal bases (laws, decrees, resolutions, regulations or other) on exceptions to the requirements for the evaluation of clinical trials based on established criteria.


Ref:
12.01.13 There are exemptions to clinical trial requirements following defined criteria.


Ref:
04.01.01 The legal provision requires one to hold a Marketing Authorization (MA) before putting a
pharmaceutical product on the market.


Ref:
MA01.02: Marketing authorization required for all products for which NRA is being assessed


Ref:
03.01.01 The legal support requires companies to have health registration before placing a drug on the market.


Ref:
MA01.01: Provision for marketing authorization and licensing for manufacturing activities


Ref:
03.06.02 A summary of product characteristics and/or summary of the technical evaluation report is(are) published and available to the public at large as basis for decision-making.


Ref:
MA08.02: Web site or other official publication with SPC-like information is available and regularly updated


Ref:
MA03.02: summary of product characteristics, patient information leaflet, labeling is published for each pharmaceutical product.


Ref:
03.03.24 There is a documented fast-track mechanism with specific registration requirements for special situations (e.g., orphan drugs, public health interest) with specific requirements, alleged risk/benefit balance.


Ref:
04.04.23 There is a documented fast-track mechanism for specific products of particular public health
interest.


Ref:
CT06.01: Defined Organizational chart & responsibilities to implement the quality management system


Ref:
CT02.01: Defined Organizational chart & responsibilities to implement the quality management system


Ref:
12.06.03 There are lines of authority reflecting the independence of decision-making in the CT approval
system from sponsors, investigators or government.


Ref:
07.06.03 There are lines of authority that reflect the independence in decision-making in the CT approval system for sponsors, researchers or the government.


Ref:
MA01.08: Legal provisions specify the limited duration of the validity of the MA and define when and in which condition the MAs should be renewed.


Ref:
04.01.05 There is a legal requirement regarding the limited duration of the validity of the MA and for
handling periodic reviews to MAs.


Ref:
03.01.07 There is a legal requirement concerning the validity term of the health registration.


Ref:
03.01.08 There is a legal requirement to enforce the regular updating of the health registration, for example, at the time of renewal or during approval of post-registration changes.


Ref:
MA09.04: Management system to ensure traceability of actions


Ref:
MA02.02: Management system to ensure traceability of actions


Ref:
MA01.10: Legal provision for applicant with definition of types and the scopes of variation and documentation required.


Ref:
04.01.06 The legal provisions require the notification to the NRA of any variations to the initial MA which
may affect the quality, safety and efficacy of the products. Specific kinds of variations can be
subject to authorization by the NRA.


Ref:
03.01.09 There are regulations that require notification to the NRA of changes/significant variations in the initial HR that may affect the quality, safety and efficacy of the products.


Ref:
03.03.12 External experts are involved in the evaluation of applications for HR.


Ref:
03.03.13 In reviewing applications for HR, an Advisory Committee of experts is involved.


Ref:
04.04.14 An advisory committee of experts is involved in the review of MAs applications.


Ref:
04.04.13 External experts are involved in the assessment of the applications for MAs.


Ref:
04.02.01 There are guidelines on the applicable requirements on quality, safety and efficacy.


Ref:
MA02.02: Specific guidelines on the legal, quality, non-clinical and clinical aspects are established and implemented.


Ref:
04.04.22 An internal tracking system is established to follow the targeted time frames (statutory or not).


Ref:
03.03.21 There are deadlines for the evaluation of the applications.


Ref:
04.04.21 There are time limit(s) for the assessment of the applications.


Ref:
03.03.08 The same criteria apply for assessing applications regardless of the origin or destination for the use of the products (e.g., domestic, imported, public/private sector).


Ref:
04.04.07 The same criteria are used for the evaluation of MA applications regardless of the source (e.g.
domestic, foreign, public/private sector) of the products concerned.


Ref:
12.01.12 Legal provisions specify the delay and/or the periodicity for reporting of adverse events during the
clinical trial.


Ref:
CT03.02: Guidelines on monitoring adverse reactions/events and periodical reporting to the NRA during the CT on health products are established and implemented.


Ref:
CT01.06: AEFIs during CT reported to NRA and/or ethics committee


Ref:
07.01.11 There are legal bases (laws, decrees, resolutions, regulations or other) requiring, during the course of the clinical trial, reporting, data collection, evaluation and monitoring of adverse events/reactions and reporting to the NRA under specific


Ref:
07.02.03 There is a guide for applicants on their monitoring of adverse reaction reports and the periodic report of their findings to the NRA.


Ref:
CT04.02: Documentation  for the acceptance of CT applications and records established


Ref:
CT02.04: Auditing system documented & implemented


Ref:
07.06.01 There is adequate internal and external expertise (education, experience and training) to evaluate CT documentation.


Ref:
03.04.07 There is a suitable office and storage space for HR files.


Ref:
04.05.07 There is an adequate equipment for MAs functions.


Ref:
04.05.06 There is an adequate office, working environment and storage space for MAs files.


Ref:
CT02.02: Roles and responsibilities of all stakeholders/institutions involved in CTs are defined


Ref:
12.03.02 There is a requirement on the composition, functions and mode of operation of the IRB/IEC.:


Ref:
12.01.06 There are legal provisions on licensing of manufacturers and importers of investigational products.


Ref:
07.01.07 There are legal bases (laws, decrees, resolutions, regulations or other) on licensing (operating authorization) of producers and importers of investigational products.


Ref:
07.06.04 There are appropriate support services in terms of communication, materials, equipment and infrastructure.


Ref:
07.03.09 A general policy on confidentiality and a code of conduct for members of the ethics board has been established and implemented.


Ref:
12.03.09 A general policy on confidentiality and a code of conduct for members of IRB/IEC is established
and implemented.


Ref:
07.03.08 A general policy on potential conflicts of interest for the members of the ethics board has been established and implemented.


Ref:
12.03.08 A general policy on potential conflicts of interest for members of IRB/IEC is established and
implemented.


Ref:
12.05.11 The same criteria are used for the evaluation of CT applications regardless of the origin of the
request (e.g. domestic, foreign, public/private sector).


Ref:
07.05.10 The same criteria are used for evaluating the documentation of the CT, regardless of the origin of the application (e.g., domestic, foreign, public/private sector).


Ref:
12.03.05 The funding for IRB/IEC is based on the fees for the services provided.


Ref:
07.03.07 There is clarity about the funding of the Ethics Board and its members.


Ref:
04.07.02 A summary of the assessment report as a basis for decision-making is published and is publicly
available (positive or negative decision).


Ref:
12.02.04 There is a guideline on monitoring of adverse reactions (give details) and on periodical reporting
of their results to the NRA.


Ref:
12.08.01 A list of CT approved and CT applications rejected, including the summary assessment reports is
published and is publicly available.


Ref:
12.07.02 The NRA retains a file of each CT approved and rejected, including the amendments approved or
rejected and the supporting documentation which includes the summary assessment reports.


Ref:
12.07.01 There is a list/data base of all the approved and rejected CT applications.


Ref:
07.08.02 The list of rejected CT applications, including summarized evaluation reports, is publicly available.


Ref:
07.08.01 The clinical trials approved by the NRA are publicly available or recorded in a domestic or international database.


Ref:
CT02.04: Regulatory authorization for importation-release of investigational products is required


Ref:
07.01.10 There are legal bases (laws, decrees, resolutions, regulations or other) requiring authorization of the import and export of investigational products.


Ref:
12.01.09 There are legal provisions requiring authority for the importation and exportation of investigational
products.


Ref:
CT01.04: Regulatory authorization for importation-release of investigational products is required


Ref:
07.04.04 The mechanisms must allow for proper harmonization and cooperation among decentralized organizations.


Ref:
CT06.01: Defined roles for Ethics Committees (ECs) at all levels


Ref:
12.04.04 The mechanisms in place allow exchange and harmonization of best practices, appropriate
cooperation and collaboration among the decentralized organizations.


Ref:
MA02.03: Auditing system documented & implemented


Ref:
MA11.01: Auditing system to the MA process is documented & implemented


Ref:
07.02.05 There are guides to authorize producers and importers of investigational products.


Ref:
12.02.06 There are guidelines for licensing manufacturers and importers of investigational products.


Ref:
12.05.14 There is a fast-track mechanism for the assessment of CT applications for specific products of
particular public health value.


Ref:
07.05.12 There is a fast-track mechanism for the evaluation of the CT decision-making and documentation with particular value on public health.


Ref:
CT02.02: Written documentation for performing activities


Ref:
CT03.03: Written documentation for performing CT authorization activities


Ref:
12.05.05 An advisory committee of experts is involved in the review of CT applications and any other
matters related to the research/investigations on human being.


Ref:
07.05.04 External experts participate in the evaluation of the documentation submitted for the approval of clinical trials.


Ref:
12.05.04 External experts are involved in the assessment of CT applications.


Ref:
07.05.05 An advisory committee of experts participates in the evaluation of the documentation submitted for the approval of clinical trials.


Ref:
MA02.01: Defined organizational chart and responsibilities to implement the Quality Management System


Ref:
04.03.01 Marketing authorization activities are organized and performed at a central level of the country.


Ref:
04.04.04 Documented procedures are implemented to periodically review the MAs granted.


Ref:
03.03.05 There are procedures to periodically review the HRs granted.


Ref:
MA08.01: Documented procedures are implemented to renew and/or to review periodically the MAs granted.


Ref:
03.03.06 There are procedures for evaluating requests for modification of HRs.


Ref:
04.04.05 Documented procedures are implemented for assessing the applications for variation of MAs.


Ref:
04.04.18 The NRA recognizes and/or uses regulatory decisions, reports or information from other NRAs or
international bodies for decision making.


Ref:
03.03.18 If the NRA recognizes or uses regulatory decisions, reports or records of other NRAs or international bodies for decision-making, there are criteria or procedures established for such recognition.


Ref:
MA09.03: Policy with written criteria for recognition of other NRA’s reports/decisions (if applicable)


Ref:
MA05.04: Policy with written criteria for recognition of other NRA’s reports/decisions (if applicable)


Ref:
03.03.17 The NRA recognizes or uses regulatory decisions, reports or records of other NRAs or international bodies for decision-making.


Ref:
04.02.02 There are guidelines on the content of Product Information Leaflets, Summary of Product
Characteristics (SPC), packaging and labelling.


Ref:
03.02.02 There are guidelines on the content of the product information package inserts, summary of product characteristics, packaging and labeling.


Ref:
03.05.01 There is an updated list/database of all products approved, suspended or recalled and rejected applications.


Ref:
03.06.01 There is a current, public list, available to the public at large, of all approved products.


Ref:
MA13.05: Information on decisions is accessible to the public


Ref:
04.07.01 A list of all the approved products is established, updated, published and made publicly available.


Ref:
04.07.03 The list/database of all the licenses withdrawn, suspended or refused is published and is publicly
available.


Ref:
03.06.03 A list/database of all licenses withdrawn, suspended or rejected is published and available to the public at large.


Ref:
04.06.01 There is an up-to-date list/data base of all the product applications received, approved, suspended
or withdrawn and of the applications refused.


Ref:
CT09.03: Management system to insure traceability of actions


Ref:
CT02.03: Management system to insure traceability of actions


Ref:
07.01.03 There is a legal basis (laws, decrees, resolutions, regulations or other) of the NRA or another delegated authority that requires a scientific ethical statement on the CT by the Ethics Review Board.


Ref:
12.01.03 There is a legal provision requesting an ethics opinion of an IRB/IEC.


Ref:
12.01.02 There is a legal provision requesting the establishment of IRB/IEC.


Ref:
07.01.02 There is a legal basis (laws, decrees, resolutions, regulations or other) of the NRA or another delegated authority that requires the establishment of the Ethics Review Board.


Ref:
CT01.01: Provision for regulation of clinical trials consistent with WHO Good Clinical Practices guideline (GCP) exists


Ref:
12.02.08 A guidance for investigation centres/clinical trial sites provides detailed information on compliance
with GCP and GLP requirements. This guidance is in line with the WHO format.


Ref:
07.07.02 The NRA maintains a record of each approved and rejected CT, including all documentation submitted for the CT review and evaluation reports.


Ref:
07.07.01 There is an internal list/database of all approved and rejected CTs.


Ref:
CT05.01: Investigational pharmaceutical products manufactured in compliance with GMP requirements with appropriate quality data submitted


Ref:
12.01.07 These is a legal provision requiring the products for investigation to comply with the applicable
GMP.


Ref:
07.01.08 There is a legal basis (laws, decrees, resolutions, regulations or others) requiring that the investigational products comply with GMP.


Ref:
04.04.02 Documented procedures/tools are implemented for the assessment of the different parts of the
application and for the assessment of specific requirements of specific classes of products


Ref:
MA06.05: Assessment of clinical data (safety & efficacy)


Ref:
MA05.02: Assessment of clinical data (safety & efficacy)


Ref:
MA05.01: Assessment of product related information (legal part and quality)


Ref:
03.03.02 There are written procedures/tools to evaluate different parts of the application.


Ref:
03.03.03 There are written procedures/tools to assess specific requirements for certain categories of products (e.g., generics, products containing new active substances, new concentrations, innovative products, etc.).


Ref:
12.02.09 There are guidelines on the control of importation and exportation of investigational products.


Ref:
07.02.08 There are guides to control the import, export or destruction of investigational products.


Ref:
04.01.02 The legislation enables the NRA to issue a marketing authorization for a pharmaceutical product,
to suspend it for a period of time and to withdraw it.


Ref:
03.01.03 The legislation empowers the NRA to request the suspension, withdrawal or cancellation of the health registration.


Ref:
MA01.04: The legal provisions enable NRA to hold, suspend, withdraw a Marketing Authorization (MA) in case there is finding on quality, safety and efficacy issues


Ref:
RS03.01: Legal basis or and relevant regulations for NRA to take actions on recall, suspension, withdrawal and/or destruction exists


Ref:
07.05.11 There are time limits for the evaluation of the CT documentation and decision-making.


Ref:
07.05.13 An internal monitoring system has been established to track the projected timeframes when evaluating a CT.


Ref:
12.05.12 There are timelines for the assessment of CT applications.


Ref:
12.05.13 An internal tracking system is established to follow the targeted time frames (statutory or not).


Ref:
03.03.09 Product information, summary of product characteristics, information brochures to the professional and to the patient (or package insert) and labeling are approved by the NRA as part of the HR.


Ref:
04.04.08 The product information, Summary of Product Characteristics (SPC), packaging and labelling is
approved by the NRA as part of the MA.


Ref:
CT06.03: Appropriate composition of Ethics Committees is defined


Ref:
CT04.01: Defined roles for Ethics Committees (ECs) at all levels


Ref:
CT04.04: Functioning and documentation of the management of Ethics Committee


Ref:
CT04.03: Appropriate composition of Ethics Committees is defined


Ref:
PV07.02: Process is established for feedback down to health facility level


Ref:
PV07.03: Process is established for feedback to public/community/patients/parents


Ref:
06.07.02 There is a System for feedback at all levels of the national health system on events associated with immunization.


Ref:
11.04.13 Consumers and patients are involved in the safety monitoring program.


Ref:
06.04.11 Consumers are involved in the safety monitoring program.


Ref:
11.01.07 There are specific requirements for reporting safety issues related to specific categories of
products (e.g. vaccines, biologicals, biological products, etc).


Ref:
11.01.08 There are specific requirements for Marketing authorization holders, manufacturers, importers,
exporters, distributors, wholesalers to designate a qualified person in charge of post Marketing
Authorization safety monitoring.


Ref:
06.01.07 There are specific requirements for Pharmaceutical Laboratories and holders of the HR to appoint a competent person in charge of monitoring post-marketing safety.


Ref:
11.02.04 There are guidelines defining the adequate scientific knowledge and training of qualified persons
and focal persons in charge of vigilance.


Ref:
06.02.04 There are standards that define scientific knowledge and proper training to qualified individuals and focal points in charge of pharmacovigilance.


Ref:
06.06.01 Safety information collected is used to make or change decisions on original marketing authorizations for drugs such as biologicals (adding information, restricting the use, product recalls, etc.).


Ref:
11.06.01 The information collected on safety is used for making or amending regulatory decisions on initial
MA (adding information on SPC, restricting the use of drug, review of PIL, recall or withdrawal of
products, etc.).


Ref:
06.06.03 The NRA maintains a master file of each ADR, ESAVI [Events Supposedly Attributed to Vaccination or Immunization], with supporting documentation.


Ref:
PV06.01: Evidence that appropriate regulatory action consistent with NRA guideline is taken in case of serious AEFI cases


Ref:
05.03.15 There is a special/specific program to detect and combat counterfeiting and illegal trade of drugs such as selling drugs of unknown origin or in non-licensed/authorized establishments


Ref:
05.03.19 A regulatory structure of coordination to combat counterfeit drugs is in place.


Ref:
05.03.03 There are documented procedures for sampling and testing of products sold or available on the market.


Ref:
09.02.04 The criteria for sample collection are based on risk assessment.


Ref:
09.02.05 There are provisions and criteria for compensation for the samples collected.


Ref:
05.03.04 The criteria for sample collection are based on risk evaluation.


Ref:
09.02.03 Documented procedures are implemented to sample the products sold or supplied on the market
and to send them for testing to the drug control quality laboratory.


Ref:
09.03.12 There is guidance on the mechanism to ensure that appropriate actions (including destruction
when necessary) have been taken.


Ref:
06.04.10 The NRA regularly organizes campaigns to promote adherence to monitoring, including the stakeholders in the national immunization program.


Ref:
11.04.12 The NRA organizes on a regular basis campaigns to promote adhesion to vigilance.


Ref:
11.04.14 The NRA has developed a proactive monitoring program to check compliance of the MAH to
applicable regulatory requirements and best practices.


Ref:
05.03.07 Decentralized activities to other agencies or authorities follow the same standards, guides and procedures.


Ref:
09.02.07 Decentralized activities to other agencies/authorities follow the standards, guidelines and
procedures as agreed/decided with the central authority.


Ref:
09.02.06 The activities are organized and performed at a central level of the country.


Ref:
05.02.08 Decentralized activities to other agencies or authorities follow the same standards, guides and procedures.


Ref:
05.03.06 The activities are organized and developed at the country’s central level.


Ref:
05.02.07 The activities are defined and organized at the country’s central level and are developed under their responsibility and control.


Ref:
09.01.04 There are guidelines for importers and exporters on the format and content of the application and
the procedure to follow for these authorizations.


Ref:
05.02.06 There are guides for importers and exporters on the format and content of applications and the procedure to follow for obtaining these authorizations.


Ref:
09.02.16 A documented procedure is implemented for communication/collaboration and cooperation with
the relevant authorities/jurisdiction in the investigations and the prosecution of breaches of regulation.


Ref:
05.03.20 There is a documented procedure for communication with health authorities and the relevant jurisdiction and for cooperation in investigations and breaches of regulations.


Ref:
05.03.14 The monitoring program is reviewed periodically and its effectiveness is evaluated.


Ref:
09.02.13 The strategy and the surveillance program are periodically reviewed and its effectiveness is
assessed.


Ref:
05.03.11 A market surveillance strategy based on inspections, laboratory analysis programs and/or other information has been established and is applied.


Ref:
05.03.12 A structured monitoring program with tasks, procedures and persons responsible to cover various pharmaceutical forms of different drugs/medicines, based on health risk criteria, has been established.


Ref:
09.02.12 A surveillance program (quality control plans and sampling strategy) is established to cover
various dosage forms of different drug/medicinal products and is based on the potential health
risks identified or expected for the patients.


Ref:
09.02.11 A market surveillance strategy based on inspection activities, control activities and other
information is established and implemented under the format of surveillance program for example.


Ref:
06.01.03 There are legal bases for Pharmaceutical Laboratories and holders of HR, which provide for the registration, collection and maintenance of data, evaluation and monitoring of the adverse reactions/events and reporting them to the NRA under the est


Ref:
11.01.04 There are legal provisions for MA holders that require the registration, data collection and
maintenance, assessment and monitoring of adverse reactions/event and to report to the NRA on
these activities.


Ref:
PV01.04: Requirements exist for manufacturer to inform NRA of any new safety signal or marketing / regulatory decisions taken in other countries based on safety and is enforced by NRA


Ref:
06.06.04 The query tool on the data collected allows the NRA to evaluate and interpret safety signs (incidence rate calculation, evaluation of causality).


Ref:
11.06.03 Query tools on the data collected enables the NRA to assess and interpret safety signals
(calculation of incidence rate, assessing of causality).


Ref:
11.02.05 There are guidelines on the criteria to determine the reporting timelines and means of reporting of
safety events (serious, expected, etc…).


Ref:
06.02.02 There are guides on the classification of safety-related events.


Ref:
06.02.05 There are guides on the criteria for determining the timing and the means to report adverse events (serious, expected, etc.)


Ref:
11.02.02 There are guidelines on classification of safety events.


Ref:
11.04.06 External experts are involved in the assessment of the information on safety transmitted through
the vigilance network.


Ref:
06.04.09 There are documented procedures for decision-making and to define recommended actions to be taken by the NRA and/or the manufacturer or other direct stakeholders.


Ref:
11.04.07 An advisory committee of experts is involved in the review of the information on safety transmitted
through the vigilance network and any other matters related to the safety of pharmaceutical
products.


Ref:
11.04.08 There are defined timelines for the assessment and decision making on ADR.


Ref:
11.04.11 There are documented quality control measures in place such as peer-review.


Ref:
11.04.10 Documented procedures are implemented for decision-making and for defining the recommended
actions to be taken by the NRA, by the MAH, by the manufacturer or any other stakeholders.


Ref:
11.01.03 There are legal provision for all stakeholders to report adverse reactions/event or any safety
issues to the NRA under defined conditions.


Ref:
11.01.05 The legal provisions require the manufacturers, distributors, importers, exporters to report the
adverse reactions/events to the MAH and NRA under specific conditions.


Ref:
11.01.11 There are specific requirements for health care institutions (clinics, hospitals, etc..) to designate a
focal person for post marketing safety monitoring.


Ref:
11.01.06 The legal provisions requires the healthcare professionals to report any adverse events/reactions
to MA holders or to the RA or another delegated authority.


Ref:
06.01.05 Legal provisions require health professionals to report adverse reactions or events to holders of the HR or the NRA or other authority in charge.


Ref:
06.01.06 There are specific requirements for reporting safety issues related to specific categories of products (vaccines, biological, biotechnological products, etc.).


Ref:
06.01.04 The legal bases require distributors and importers to report adverse reactions or events to the holder of the HR or the NRA under the established requirements.


Ref:
05.04.11 There are defined criteria for determining the appropriate means and level of communication of the recall with a feedback mechanism.


Ref:
09.03.10 There are defined criteria to determine the appropriate means and the level of communication of a
recall with a feedback mechanism.


Ref:
05.04.04 There is a legal requirement for a registration system in the distribution chain to ensure batch traceability to facilitate an effective recall system.


Ref:
05.04.05 There is a legal provision that empowers the NRA to order the elimination of defective or noncompliant products.


Ref:
09.03.02 The legislation enables the RA to suspend or stop the manufacture, import, export, distribution,
sale or use of pharmaceutical products.


Ref:
09.03.01 The legislation enables the RA to instruct for the recall of pharmaceutical products (e.g. due to
defects, inappropriate labelling or packaging or contamination ).


Ref:
09.03.04 There is a legal provision concerning the disposal of defective/non-compliant products.


Ref:
05.04.08 There are legal provisions instructing manufacturers, importers and exporters about the procedure to be used for the recall and elimination of defective or noncompliant products.


Ref:
09.03.05 There is a legal requirement for manufacturers/importers to notify the NRA before initiating a
recall and upon request to inform on the progress.


Ref:
09.03.06 There is a legal requirement for manufacturers/importers to notify the NRA about product
complaints regarding quality.


Ref:
05.04.06 There is a legal requirement for manufacturers/importers to notify the NRA of the beginning of a recall.


Ref:
09.03.03 There is a legal requirement for records to be maintained within the distribution chain to ensure
batch traceability and facilitate an effective recall system.


Ref:
05.04.01 The legislation allows the NRA to require drug recall in a situation of violation of current rules.


Ref:
05.04.07 There is a legal requirement for manufacturers/importers to notify the NRA of complaints about the quality of the products.


Ref:
05.04.02 The legislation allows the NRA to suspend or prevent the manufacture, import, export, distribution, sale and use of drugs.


Ref:
05.04.03 The legislation allows the NRA to suspend or prevent the marketing or promotional campaigns and stop the distribution of promotional material.


Ref:
06.04.04 There are documented procedures in the NRA to analyze safety trends for detection of signs.


Ref:
06.04.05 A system has been established for prioritizing safety signs according to the public health impact and to demonstrate that high-risk issues are investigated immediately, or in a first instance.


Ref:
11.04.04 Documented procedures are implemented in the NRA to analyse the safety trends for signal
detection.


Ref:
11.04.05 A well-established system is in place for prioritization of drug safety signals according to the public
health impact and to demonstrate that high risk issues are investigated immediately or in the first
instance.


Ref:
PV05.01: Demonstrated capacity of the reporting system (active or passive, sentinel or countrywide/statewide) with satisfactory sensitivity


Ref:
PV05.04: A national database or system for collating, managing and retrieving AEFI reports exists


Ref:
05.03.10 There are documented procedures to collect information, detect and combat counterfeiting, substandard products, products without registration and illegal trade of drugs such as selling drugs of unknown origin or in non-licensed/authorized establi


Ref:
09.02.10 Documented procedures/programs are implemented for collecting information, detecting and
combating non-compliant products.


Ref:
09.03.08 Documented procedures are implemented in the NRA to assess the notification of recalls and
product complaints.


Ref:
09.03.09 Documented procedures are implemented in the NRA to ensure the removal of defective
products, organize an effective recall and disposal of defective/non-compliant products.


Ref:
09.03.13 The NRA approves the closure of a recall and certifies the disposal of defective/non-compliant
products.


Ref:
05.04.09 There are documented and implemented procedures in the NRA to ensure evaluation of the notification of recalls and complaints about products.


Ref:
05.03.13 There are procedures describing the research of cases or suspicions of products with quality deviations.


Ref:
PV01.02: Guidelines exist, are published and accessible, distributed or and available when needed to all staff involved in AEFI surveillance and are actively used


Ref:
06.02.03 The guide on safety reports contributes to the scientific evaluation of drug risk/benefit balance.


Ref:
06.02.07 Existing Guides for the monitoring of adverse events with biological products are published and distributed to those involved in monitoring.


Ref:
11.02.03 The guidance on safety reporting provides for a scientific evaluation of the risk/benefit balance of
medicines.


Ref:
06.04.07 The lack of effectiveness due to drugs suspected of being counterfeit is examined during the evaluation process.


Ref:
06.04.08 The lack of effectiveness due to biological products suspected of being counterfeit is examined during the evaluation process.


Ref:
11.04.03 A documented procedure is implemented to follow implementation of pharmacovigilance plan (see
also module 4 on MA)


Ref:
11.04.15 MAH, manufacturers, importers, exporters, distributors are periodically inspected by inspectorate
on pharmacovigilance practices.


Ref:
06.04.02 External information (sources of information and reference materials) for decision-making for suspicious events attributed to immunization and safety monitoring is readily available.


Ref:
PV05.02: Documented evidence of appropriate investigations or sufficient elements indicative of capacity to investigate


Ref:
11.04.01 External information (information sources and reference materials) for decision making on ADR
and safety monitoring are readily available.


Ref:
11.04.02 Documented procedures are implemented in the NRA to register and to assess day to day ADR
reports.


Ref:
11.04.09 An internal tracking system is established to follow the targeted time frames (statutory or not).


Ref:
06.04.06 An internal monitoring system (legal or otherwise) has been established to follow the timeframes scheduled in the process.


Ref:
06.04.03 There are documented procedures in the NRA to record and evaluate daily adverse reaction reports.


Ref:
06.04.01 External information (sources of information and reference materials) for decision-making on adverse drug reactions and safety monitoring is readily available.


Ref:
PV05.03: Evidence of timely reporting and investigations is documented


Ref:
09.01.11 There are records or a data base kept by the RA on imported and exported products.


Ref:
09.03.14 The NRA keeps the records or an information/data base on recalled and disposed defective/noncompliant products.


Ref:
09.02.14 The RA keeps the records or information/data base on the samples collected of non-compliant
products.


Ref:
05.04.13 The NRA approves the end of the recall and confirms the elimination of defective or noncompliant products.


Ref:
05.04.14 The NRA maintains records or information/database of recalls and defective or noncompliant products that have been discarded.


Ref:
05.03.09 The mechanisms provide for appropriate collaboration between decentralized organizations.


Ref:
05.03.18 A partnership agreement has been established and implemented between customs or another oversight body for market control activities.


Ref:
09.01.08 The mechanisms in place allow exchange and harmonization of best practices, appropriate
cooperation and collaboration among the decentralized organizations.


Ref:
09.02.08 In case of decentralization, a mechanism of exchange of information is established and
implemented in order for the decentralized organization to receive requests and/or directives from
the central authority and to report to it.


Ref:
05.02.14 There is collaboration or an agreement with the customs or other oversight agency in the control of imports and exports.


Ref:
05.02.10 The mechanisms provide for appropriate cooperation and collaboration among decentralized organizations.


Ref:
05.02.09 In the case of decentralization, an information exchange mechanism is established and implemented for the decentralized organization to receive applications and/or directives from the central authority and also to report to it.


Ref:
05.03.08 In the case of decentralization, an information exchange mechanism is established and implemented for the decentralized organization to receive applications and/or directives from the central authority and also to report to it.


Ref:
09.01.12 There is a collaboration/agreement with the Customs or other enforcement agencies on the
control of import and export.


Ref:
09.03.11 The effectiveness of the recall system is regularly validated.


Ref:
05.04.12 The NRA uses mechanisms to assess the effectiveness of the recall of a defective product from the market.


Ref:
06.01.09 The legal bases establish the delay and/or frequency for reporting adverse events.


Ref:
PV01.01: Legal provisions for pharmacovigilance exist in the public and or private sectors as appropriate


Ref:
11.01.02 The legal provisions require the NRA to implement a vigilance system in order to collect the
information useful in the surveillance of medicines, to evaluate such information and to take the
appropriate decisions.


Ref:
11.01.09 There are legal provisions to define the terminology used such as adverse event, adverse
reaction, serious adverse event, etc.


Ref:
11.01.10 The legal provisions specify the delay and/or the periodicity for reporting of adverse events.


Ref:
06.01.02 The legal bases require the NRA to implement a monitoring system to collect useful information in pharmacovigilance, to evaluate this information and make decisions.


Ref:
06.01.08 There are legal bases for defining the terminology used, such as adverse event, adverse reaction, serious adverse events, etc., for example.


Ref:
05.01.08 There is a legal provision stipulating that there must be at least one person responsible for quality for each importer, exporter, wholesaler and distributor.


Ref:
09.01.03 The legal provisions require the importers and exporters to register information on the origin and
the destination of the products imported and exported.


Ref:
09.01.02 The legal provisions require the importers/exporters to hold an authorization for each importing
and exporting act of a pharmaceutical product.


Ref:
09.01.01 The legal provisions require the importer to hold a marketing authorisation or to have its
pharmaceutical products registered before organising the importation activities.


Ref:
05.02.05 Legal provisions require exporters to record information about the origin and destination of exported products.


Ref:
05.02.03 Legal provisions require exporters to have authorization for each export of a drug.


Ref:
05.01.09 If there are legal provisions for exemptions from requirements for licensing or health authorization, the criteria to grant them are formally established.


Ref:
05.02.04 Legal provisions require importers to record information about the origin and destination of imported products.


Ref:
05.01.07 Legal provisions require notification to the NRA of changes/significant variations of the initial license that may affect the quality, safety and efficacy of the products.


Ref:
05.01.06 Legal provisions require importers, exporters, wholesalers and distributors to comply with the application of Good Storage Practice and distribution to obtain their health license or authorization.


Ref:
05.01.05 There are legal provisions concerning repackaging/relabeling.


Ref:
05.01.04 The legislation empowers the NRA to suspend or restrict drug import, export, distribution and dispensing.


Ref:
05.01.02 The legislation requires a company that exports or attempts to export drugs and biological products to hold a specific license or health authorization to operate, issued by the NRA.


Ref:
05.01.02 The legislation requires a company that acts as drug wholesaler or distributor to hold a specific license or authorization to operate.


Ref:
05.01.01 The legislation requires a company that imports or attempts to import drugs and biological products to hold a specific license or health authorization to operate, issued by the NRA


Ref:
05.02.01 Legal provisions require imported drugs to have health registration prior to the import procedure.


Ref:
05.02.02 Legal provisions require importers to have authorization for each import of a drug.


Ref:
06.07.01 Information on ADRs, ESAVIs and the measures taken on safety monitoring is communicated to the public, including the safety notice.


Ref:
11.07.01 Information on ADR and safety monitoring measures taken are communicated to the public,
including the safety notice.


Ref:
PV07.01: Periodic (quarterly or yearly) feedback on AEFI including summary and specific investigation reports


Ref:
05.03.05 There are provisions and criteria for the compensation of the samples collected.


Ref:
05.03.02 There is a legal provision for sampling and analysis of samples of marketed drugs.


Ref:
05.03.01 There are legal provisions on the definition of counterfeit drugs and pharmaceutical crime.


Ref:
09.02.02 There is a legal provision for sampling and testing samples of pharmaceutical products on the
market


Ref:
09.02.01 There are legal provisions to deal with non-compliant products.


Ref:
09.01.10 Documented procedures are implemented to issue import and export certificates/authorizations, in
standardized formats.


Ref:
05.02.11 There are documented procedures in the NRA to evaluate drug import or export applications.


Ref:
05.02.12 There are documented procedures for granting import authorizations and export certificates with standardized forms.


Ref:
09.01.09 Documented procedures are implemented in the NRA to assess the application for import and
export certificates/authorizations.


Ref:
09.09.01 If there are national reference materials/standards for chemical substances, there is a system to establish and qualify such materials.


Ref:
LA02.02: A system in place to establish guidelines on the selection and use of references/standards materials for health products quality control purposes.


Ref:
LA08.01: System in place to establish and qualify national reference standards (in IU if appropriate)


Ref:
LA05.01: If national (secondary) reference standards/materials exists, there is a system and procedures in place to establish and qualify such materials.


Ref:
14.08.01 There is a system to establish and qualify the national reference standards/materials.


Ref:
09.08.01 There is a Validation Master Plan, non-abridged methods have been validated and abridged methods have been verified.


Ref:
09.05.08 There are strategies, programs and procedures for implementation and validation of new/improved tests.


Ref:
LA06.01: Validation master plan exist, non-compendial tests have been validated and compendial tests have been verified


Ref:
LA06.02: Procedures for transfers of validated methods is documented (e.g. from manufacturer)


Ref:
14.05.08 There are strategies, programs and procedures for the introduction and validation of new/ improved tests.


Ref:
09.08.02 There are procedures for the transfer of validated methods (e.g., from the manufacturer).


Ref:
LA03.02: Validation master plan exists, tests must be validated or verify as required


Ref:
14.01.04 The legislation empowers a RQCL to perform quality control testing of the pharmaceutical
products and to issue official results.


Ref:
14.01.03 There is a legal provision on the designation of analysts and their powers.


Ref:
LA02.01: Documentation for performing testing activities, handling OOS results and retest policy exists


Ref:
09.01.04 The legislation empowers the OMCL to develop quality control tests for drugs and vaccines and to issue official results.


Ref:
LA01.02: Clearly defined responsibilities for scientific/technical input during the pre and post licensing period - Critical


Ref:
09.06.01 There is a mechanism for appointing analysts and defining their responsibilities and powers in the OMCL.


Ref:
LA07.01: The list of hazardous substances is available


Ref:
14.09.01 A list of hazardous substances is available and updated.


Ref:
14.09.03 A documented procedure are implemented for the storage, handling and disposal of hazardous
substances.


Ref:
09.11.01 The lists of hazardous substances are available.


Ref:
09.11.03 There is a procedure for the storage, handling and disposal of hazardous substances.


Ref:
LA07.03: There is a procedure for the storage, handling and disposal for hazardous substances


Ref:
LA07.02: There is a procedure for identification, safe storage, handling and disposal for hazardous substances.


Ref:
14.07.07 There are adequate support services provided in terms of transport and communication.


Ref:
14.07.05 Plans for cleaning, calibration and maintenance activities are established and implemented.


Ref:
09.07.06 Adequate support services are provided in terms of transport and communication.


Ref:
09.07.05 There is a plan for equipment maintenance and calibration.


Ref:
LA05.03: There is a calibration and maintenance plan


Ref:
LA08.04: Regular supply system for reference standards/materials


Ref:
14.08.03 Documented procedures are implemented for the appropriate handling and use of reference 
standards/materials


Ref:
14.08.04 Documented procedures are implemented for sourcing, preparation, storage and use of reagents
of assured quality.


Ref:
LA05.02: Appropriate handling and use of reference standards/materials


Ref:
14.08.02 There is a regular supply system for reference standards/materials.


Ref:
09.09.03 There is a regular supply system that ensures the availability of reference materials/standards.


Ref:
09.09.04 There is a (are) procedure(s) for the proper handling, use and verification of reference materials/standards.


Ref:
09.09.05 There is a (are) procedure(s) for reception, storage and use of reagents with guaranteed quality.


Ref:
09.09.06 There is a (are) procedure(s) for the preparation of reagents in the laboratory.


Ref:
09.09.08 There is a regular supply system of reference materials or standards.


Ref:
LA08.02: Appropriate handling and use of reference standards/materials


Ref:
LA08.03: Appropriate handling and use of reagents of assured quality


Ref:
09.09.07 There are records of the preparation and standardization of volumetric solutions.


Ref:
09.12.02 There is a formal agreement/contract defining the scope and responsibilities of each party.


Ref:
09.12.03 The agreement takes into consideration the points relating to conflicts of interest and confidentiality of the contracted laboratory.


Ref:
LA06.02: A formal agreement/contract defines the nature of the services provided, the duties and responsibilities of each stakeholder in particular as regard conflicts of interest and confidentiality issues.


Ref:
14.10.03 A documented procedure is implemented to ensure that the requirements that apply to the NDCL
are also applied in the same way to the sub-contracting organization.


Ref:
09.12.04 The formal agreement/contract ensures that the requirements established by the OMCL are applied in the same way by the subcontracted organization.


Ref:
09.12.05 There is a documented procedure or mechanism that ensures the technical competence of the subcontracted laboratory.


Ref:
09.10.01 Systematic verification (checking) of compliance with specifications is conducted.


Ref:
LA09.01: Compliance with specifications is systematically checked


Ref:
14.02.01 There is a defined policy for testing in the pre-marketing and post-marketing period.


Ref:
09.02.02 Responsibilities are clearly defined for the scientific-technical support of the OMCL in the pre-marketing and post-marketing periods.


Ref:
LA03.01: There is a defined policy for testing health products in the pre- and post-marketing phases.


Ref:
LA10.02: Appropriate performance in proficiency schemes, collaborative studies and/or inter-laboratory comparisons


Ref:
14.04.12 The RQCL participates in a proficiency testing scheme and in external quality assurance
programs


Ref:
09.04.12 There is evidence that the OMCL participates in international schemes for performance studies, collaborative studies and/or inter-laboratory comparisons.


Ref:
LA10.01: Evidence of regular participation


Ref:
09.04.13 The results show adequate results in performance evaluation arrangements, collaborative studies and/or inter-laboratory comparisons.


Ref:
09.02.08 There are established guidelines on handling appeals against the decisions of the OMCL.


Ref:
09.05.01 There are procedures or mechanisms for effective communication with users and stakeholders.


Ref:
14.05.01 Documented procedures are implemented for meetings with clients and other interested parties.


Ref:
09.02.07 There are established guidelines on handling complaints and grievances against the activities of the OMCL.


Ref:
LA03.03: Planning of testing activities is established and implemented.


Ref:
14.05.03 Documented procedures are implemented for performing the testing.


Ref:
09.05.04 There is proper test planning and coordination of activities.


Ref:
09.05.03 There are written procedures for developing tests.


Ref:
LA07.01: The responsible staff is designated for the safety program's management


Ref:
14.09.02 The responsible staff is designated for the management of a safety programme.


Ref:
09.11.02 A team leader is appointed to manage the safety program.


Ref:
LA07.02: The responsible staff is designated for the safety program's management


Ref:
09.05.12 The criteria adopted by the OMCL for the evaluation of a product are selected according to the active principle and the types of samples to be evaluated, regardless of product origin.


Ref:
14.05.13 The same criteria are used for testing all products from domestic, foreign, public and private 
facilities.


Ref:
LA04.04: The same criteria are used for testing products from domestic, foreign, public and private facilities.


Ref:
LA04.02: Specifications and validity criteria are defined for all tests


Ref:
09.05.07 Specifications and validity criteria for each test are defined.


Ref:
09.05.09 There is a (are) procedure(s) for the evaluation of test results and decision-making.


Ref:
14.05.09 Documented procedures are implemented for the evaluation of test results and decision-making.


Ref:
09.10.05 Monitoring and trend analysis are carried out for data obtained from reference materials.


Ref:
LA09.05: Monitoring and analysis of data trends for reference standards/materials


Ref:
14.05.14 A documented procedure is implemented to issue certificates in a standardized format.


Ref:
09.13.02 Test records are kept readily available at the OMCL.


Ref:
09.13.03 There is a standard report form for test results issued by the laboratory, with the information necessary for the correct identification of the applicant, sample, type of test conducted, results and conclusions of the analysis of a sample.


Ref:
09.05.11 There is a standard analytical worksheet form, or whatever the name given to it, to record information about the sample, test procedures, raw data obtained in the analysis, calculations (where applicable) and test results.


Ref:
LA08.03: A documented procedure is implemented to ensure that all reports generated as part of regulatory functions have a standardized format.


Ref:
14.05.11 There is a standard format for recording and reporting results of analysis (work sheet and CoA).


Ref:
14.11.02 Testing records/reports are maintained and are readily available at the RQCL.


Ref:
14.11.03 The RQCL issues certificates of analysis under its own name or in the name of the NRA.


Ref:
LA04.01: Documentation for performing testing activities, handling OOS results and retest policy exists


Ref:
09.05.10 There is a (are) procedure(s) to handle out-of-specification results that include the policy that include [sic] the retesting policy.


Ref:
14.05.10 Documented procedures are implemented for handling out-of-specification results, including a
retesting policy.


Ref:
09.12.01 The list of all trials contracted by the OMCL with other laboratories and organizations is established.


Ref:
14.10.01 A list of all the categories of testing activities the NDCL sub-contacts to another laboratory or
organization is established.


Ref:
LA05.02: Documentation relevant to operational manuals, SOPs, log books, records of use, maintenance and calibration of equipment exist and are updated


Ref:
14.07.03 Documented procedures are implemented for the correct use of the equipment according to the 
manufacturer's instructions.


Ref:
14.07.04 There are operation manuals and logs books for the equipment (registers of
operations/use/maintenance/calibration)


Ref:
09.07.04 There are operation manuals, operating procedures and their corresponding records (use and maintenance).


Ref:
LA04.05: A documented procedure including special considerations for manipulating health products in the laboratory must be implemented.


Ref:
09.05.06 There are procedures for product category testing that require special considerations.


Ref:
14.05.06 Documented procedures are implemented for testing specific ranges of products.


Ref:
14.07.06 There are qualification protocols and reports for the equipment.


Ref:
LA05.04: There are qualifications protocols and reports


Ref:
LA09.04: Monitoring and analysis of data trends for laboratory results


Ref:
09.10.04 Monitoring and trend analysis are carried out for laboratory result data.


Ref:
09.11.04 Staff immunization requirements are defined and have been completed.


Ref:
LA07.03: Staff health requirements are defined, and monitoring.


Ref:
LA07.04: Staff immunization requirements are defined, and monitoring of staff immunization records is managed for accessing the required premises or and using equipment


Ref:
LA01.01: There is a legal provision to establish a quality control laboratory or access/sub-contract the required services


Ref:
14.01.01 There is a legal provision for the establishment of a Regulatory Quality Control Laboratory
(RQCL).


Ref:
09.01.01 There are legal bases for the establishment of an Official Medicines Control Laboratory (OMCL) or operational agreements to use an External Control Laboratory.


Ref:
09.01.03 If the OMCL is not part of the NRA, there is a legal basis that establishes the relationship mechanisms between them.


Ref:
LA01.01: National Control Laboratory (NCL) established or operational agreement to use external QC laboratory


Ref:
14.05.05 Documented procedures are implemented for handling and storage of in-coming and retention
samples.


Ref:
14.05.02 Documented procedures are implemented for preparation and storage of standards, samples, etc.


Ref:
09.05.05 There are procedures for handling and retention of samples.


Ref:
09.02.04 There are general guidelines on sampling.


Ref:
14.07.01 There is adequate working space, work environment and storage space for laboratory activities.


Ref:
09.07.01 There is a suitable workspace, environment and storage for the activities of the laboratory.


Ref:
09.07.02 There are adequate equipment and instruments for conducting the tests.


Ref:
LA05.01: Building and premises are adequate to host National Control Laboratory (NCL) activities


Ref:
LA07.04: required facility specification and equipment exist to implement safety program and procedure


Ref:
09.07.08 The installed and analytical capacity of the OMCL is sufficient to meet all requests for analysis.


Ref:
LA11.01: Laboratory facilities should be adequate to host regulatory activities.


Ref:
14.07.02 Equipment and instruments for testing activities are adequate and well maintained.


Ref:
09.07.07 The ratio of analysts/laboratory area allows OMCL activities to be carried out efficiently.


Ref:
09.13.01 There is a list/database of all the products tested.


Ref:
14.11.01 There is a list/data base of all the products tested.


Ref:
LA04.03: Documented procedures are implemented for dealing with counterfeited products or products suspected to be counterfeited.


Ref:
09.10.03 Regulatory actions are adopted in case of noncompliance.


Ref:
LA09.03: Regulatory action taken in case of non compliance


Ref:
LA08.01: There are methods in place to identify noncompliance (products or test results)


Ref:
14.05.07 There are specific documented procedures to deal with non-compliant products.


Ref:
14.05.12 Documented procedures are implemented for follow-ups of non-compliant products to enforce
compliance (including timeframes).


Ref:
09.10.06 The results obtained are compared with those of the manufacturer.


Ref:
LA09.06: Comparison of results with those of manufacturer


Ref:
14.03.01 Testing activities are organized and performed at a central level of the country.


Ref:
14.03.02 Decentralized activities to other agencies/authorities follow the standards, guidelines and
procedures as agreed/decided with the central authority..


Ref:
14.03.03 In case of decentralization, a mechanism of exchange of information is established and
implemented in order for the decentralized organization to receive requests and/or directives from
the central authority and to report to it.


Ref:
14.03.04 The mechanisms in place allow exchange and harmonization of best practices, appropriate
cooperation and collaboration among the decentralized organizations.


Ref:
09.03.01 Testing activities are organized and developed at the country’s central level.


Ref:
09.03.02 Decentralized activities of other agencies/authorities follow the same standards, guides and procedures. (Does not apply if the activities of the OMCL are centralized.)


Ref:
09.03.03 In case of decentralization, an information exchange mechanism is established and implemented for the decentralized organization to receive requirements and/or directives from the central authority and report to it. (Does not apply if the activit


Ref:
09.03.04 The mechanisms allow for appropriate collaboration among decentralized bodies. (Does not apply if the activities of the OMCL are centralized.)


Ref:
05.04.01 Documented procedures are implemented for meetings with applicants before an application is
officially lodged.


Ref:
05.04.02 Documented procedures/ checklists are implemented to assess the applications for licensing.


Ref:
05.04.04 A documented procedure is implemented for assessing the applications for variation of licenses.


Ref:
05.04.06 A documented procedure is implemented for decision-making.


Ref:
05.04.07 Documented procedure is implemented to issue the licence in a standardized format.


Ref:
LI06.01: Licensing processes are planned and developed considering the regulation to be implemented, the availability of resources (in particular human) and the process verification needed


Ref:
LI07.01: Assessment of the manufacturing license application


Ref:
LI07.02: Documented procedures/standard checklists are implemented to assess the applications for licensing the retailers. A standardized format is drawn up and used to report the outcome of each assessment performed.


Ref:
LI08.02: Provision and Documented procedures are implemented to issue the various types of license in standardized formats.


Ref:
04.05.06 There is a procedure for making decisions on license issuance, renewal, modification or revocation.


Ref:
04.05.02 There is a procedure/checklist for evaluating licensing applications.


Ref:
04.05.01 There is a procedure to meet with applicants before the application is officially submitted.


Ref:
04.05.10 There is a standard operating procedure (SOP) in place to ensure participation and communication between evaluators and inspectors for the enforcement and application of GMP.


Ref:
RS05.04: Information on marketed products and authorized companies is publicly available


Ref:
03.09.06 The information on decisions are publicly available, including the negative decisions in specific
cases (i.e. when legislation permits) in a timely manner.


Ref:
02.09.06 The decision-making process related to regulatory activities such as issuance or denial of a registration, application of health safety measures, batch release, approval or denial of a clinical trial, authorization to operate a manufacturing faci


Ref:
02.01.05 When more than one regulatory body/authority is involved in regulatory activities, the legislation defines the channels of coordination, and there is an administrative mechanism defined for it.


Ref:
03.01.02 If more than one institution is involved, legislation provides for coordination/linkage among these
institution and the respective empowerment is defined.


Ref:
03.06.03 Provisions concerning fee reductions or exemptions to ensure the availability of vital or life-saving
drugs for a limited market are provided.


Ref:
02.06.03 There are provisions relating to reduction or exemption of dues, taxes, tariffs or fees to guarantee the availability of essential drugs for survival or those with very limited market.


Ref:
03.09.01 The legislation stipulates the requirements on confidentiality and transparency.


Ref:
02.12.01 The legislation establishes requirements for other institutions to be able to monitor, supervise and review the performance of the NRA for the performance of the regulatory functions assigned to it.


Ref:
RS01.03: A policy to establish and implement  a Good Regulatory Practices (GRP)


Ref:
RA19.02: All regulations should be enacted and published


Ref:
RS05.02: Information related to legislation and regulations is publicly available.


Ref:
03.09.03 Information on legislation, regulations, procedures and guidelines are publicly available and are
kept up to date on websites or other mechanisms used to ensure the proper availability of
information.


Ref:
02.09.04 The information on laws, regulations, procedures and guidelines is publicly available on Web pages or other mechanisms that ensure the adequate availability of information and is kept duly updated.


Ref:
02.09.08 Information on the results of the actions of the NRA in all its functions is publicly available and is constantly updated.


Ref:
03.06.06 The NRA is obliged to periodically publicize its budget.


Ref:
RA12.01: Legislation and or regulations exist to recognize reports or decisions emitted by other regulatory institutions.


Ref:
03.09.09 A guideline on complaints and appeals against regulatory decisions is available.


Ref:
02.09.10 Guidelines on complaints and appeals from decisions of the NRA in all its functions are available.


Ref:
02.03.05 Channels of communication are established between the structures within the NRA in charge of managing and organizing work activities, when there are several, and between these and other departments/units of the NRA.


Ref:
03.02.05 Communication channels among such bodies are established.


Ref:
02.02.09 The specific legal bases of the NRA offer adequate support, procedures and responsibilities in combating counterfeiting.


Ref:
02.02.08 The specific legal bases of the NRA give it the authority to conduct inspections in establishments where activities relating to regulated drugs are carried out or intended to be carried out, and to appoint inspectors to conduct them.


Ref:
03.01.06 The legal provisions specify that the NRA has the power to/or the delegation to issue a written
notice of violations to companies and recommend their prosecution.


Ref:
03.01.05 The legal provisions specify that the NRA has the delegation, the enforcement powers and
responsibilities to deal with non-compliant products.


Ref:
03.01.04 The legal provisions specify that the NRA has the power to/or the delegation for appointing special
officers/inspectors and provides them with adequate powers to carry out inspection of
pharmaceutical products and practices.


Ref:
02.09.12 The NRA consults or involves specific sectors of civil society (such as NGOs, representatives of health professionals, industry, consumers and patients) during the development of guides or guidelines.


Ref:
03.09.11 The NRA consults or involves specific sectors of the civil society (such as NGOs representing
health professionals, the industry, consumers and patients) during the development of guidelines.


Ref:
03.01.08 The legal provisions enable the NRA to set up technical/scientific advisory committees for regulatory purposes.


Ref:
03.02.06 There is a scientific body to advise the NRA on scientific matters and future orientations.


Ref:
02.03.06 There is a Scientific Committee to advise the NRA on scientific topics of interest and future directions.


Ref:
RS07.01.Legal basis or and regulations for the establishment of internal or external experts or and advisory committees


Ref:
03.10.01 There is a documented Code of conduct for staff members involved in drug regulatory functions.


Ref:
03.08.07 There is a general policy on confidentiality and a code of conduct for external experts and
members of advisory committees.


Ref:
02.10.01 There is a documented “Code of Conduct” for members of staff involved in regulation functions.


Ref:
02.08.07 There is a general policy on confidentiality and code of conduct for “ad hoc” external experts and members of the Advisory Committee.


Ref:
RS05.08: Code of conduct including management of conflicts of interest is published and enforced


Ref:
03.13.01 The NRA uses computerized systems for automation of repetitive functions and for reporting
activities.


Ref:
02.13.02 The NRA uses computer systems for the efficient handling of data so that information is collected, entered into a database and retrieved in reports for queries.


Ref:
02.13.01 The NRA uses computer systems to automate repetitive activities and for activity reports.


Ref:
03.13.02 The NRA uses computerized systems for data management and for enhancing data import/export
capacity.


Ref:
02.13.03 The NRA uses computer systems to access technical/scientific information.


Ref:
03.13.03 The NRA uses computerized systems for accessing technical/scientific information.


Ref:
RS05.03: Information on decisions is accessible to the public


Ref:
02.09.07 Information on decisions is publicly available, including negative decisions in specific cases (where the law allows) in a timely manner.


Ref:
02.13.05 The NRA has its own Web page or has an agreement to use that of other institutions.


Ref:
03.13.05 The NRA has its own website or has made an arrangement to use others.


Ref:
02.01.07 If there are decentralized activities conducted by other agencies/authorities, they follow the same standards, guidelines and procedures.


Ref:
RS01.02: Legislation or and regulation defines the institutions involved in the vaccine regulatory system, their mandate, functions, roles, responsibilities and enforcement power


Ref:
02.01.04 The legislation defines the institutions involved in the drug regulatory system, their powers, functions, roles, responsibilities and tasks.


Ref:
02.01.02 The responsibilities, functions, organization, powers and structure of the body(ies) responsible for drug regulation are clearly defined in the incorporation documents and other complementary documents, particularly in relation to the powers and


Ref:
02.01.02 The responsibilities/functions/organization of each of these authorities are clearly defined, in
particular as regards the scope of the regulation (regulatory functions) they have under their
control.


Ref:
03.03.02 The Vision and the Mission Statement for the NRA is established.


Ref:
RA02.01: Top management provides direction for the NRA by developing its own mission, vision and values involving stakeholders and employees.


Ref:
02.04.02 The NRA has established and declared its vision and mission.


Ref:
02.10.05 The NRA maintains independence from drug researchers, producers, distributors and wholesalers.


Ref:
RS02.02: Independence of NRA from procurement system / institutions


Ref:
RS02.01: Independence of NRA from researchers, manufacturers, distributors and wholesalers


Ref:
02.10.06 The NRA maintains independence from the drug provider system/institutions.


Ref:
02.12.03 The NRA prepares general and thematic reports at regular intervals on the regulatory functions/processes executed, which are sent to the body(ies), institution(s) or entity(ies) responsible for the supervision and review of the NRA.


Ref:
RS06.02: Performance indicators established and used for monitoring progress to meet strategic plan or and institutional development plan


Ref:
03.03.01 The NRA has established an Institutional Development Plan which is implemented and updated.


Ref:
02.04.01 The NRA has an implemented and updated institutional development plan.


Ref:
RS03.02: System based on documented communication to appropriate level of the distribution system with feedback mechanism


Ref:
RS05.06: All publicly available information is kept up-to-date


Ref:
RA01.01: Legislation or and regulation defines the institutions involved in health product regulatory system, their mandate, functions, roles, responsibilities and enforcement power


Ref:
02.01.03 All regulatory functions are under the responsibility and supervision of at least one regulatory body/authority.


Ref:
03.06.01 The sources of funding of the NRA to perform its regulatory functions are defined.


Ref:
02.06.01 Sources of funding are established for the NRA to carry out all its regulatory functions.


Ref:
02.02.03 The development of the regulations involves the Regulatory Authority responsible for their implementation and enforcement.


Ref:
RS01.01: Legislation or and regulation defines the medicinal products for human use to be regulated


Ref:
RS03.03: System based on documented confirmation that appropriate, batch traceable, action and/or destruction when necessary has been taken


Ref:
02.11.02 The NRA has the necessary and adequate equipment to perform the regulatory functions.


Ref:
03.11.02 The equipment provided for performing the regulatory functions are adequate.


Ref:
03.11.01 The work space and work environment are adequate.


Ref:
03.08.08 The NRA is involved in a global network with relevant scientific associations and professional
societies.


Ref:
02.08.10 The NRA participates in a global network with prestigious scientific associations and professional societies.


Ref:
RS05.07: Appropriate mechanism for management of confidential information and or proprietary material exists


Ref:
03.08.09 There is a documented mechanism to manage potential conflicts of interest of internal and external experts and members of committee by collecting declarations of interests


Ref:
02.09.02 There is an adequate mechanism for management of confidential material/information.


Ref:
03.06.02 The scale of fees for regulatory services provided are established and published, including any
preferences applied to local products or industry.


Ref:
02.06.02 The amounts of fees, taxes, tariffs or dues payable for the services provided by the NRA are published.


Ref:
03.06.05 The NRA has the authority and the procedures in place to collect fees and internally utilize the
generated funds.


Ref:
02.06.06 The NRA has the authority to collect and internally use the funds generated.


Ref:
RA05.02: Potential risks should be defined and monitored through an action plan for each key process.


Ref:
02.04.03. A qualified quality manager is designated as responsible for the implementation of the QMS


Ref:
02.05.06 A qualified person is designated as responsible for developing and implementing the quality management system.


Ref:
RS04.03: Human resources designated and assigned to implement a quality management system


Ref:
03.05.05 A qualified person is designated as responsible for the development and implementation of the
Quality Management System.


Ref:
RA06.12: The NRA periodically reviews its organizational performance and estimates the impact of its regulatory activities based on the mandate received.


Ref:
02.05.13 The Management of the NRA reviews the organization of the QMS in accordance with the regulatory bases at least once every 12 months and documentary evidence is available.


Ref:
03.05.12 The top management of the NRA reviews on a regular basis, at least once every 12 months, the
QMS to evaluate its efficiency as well as its effectiveness. Records of the review are maintained.


Ref:
RA08.03: Training plan developed, implemented and updated at least once a year.


Ref:
RS06.03: Training plan developed, implemented and updated


Ref:
02.07.08 A training plan is established for all staff to meet the identified needs.


Ref:
03.07.08 A training plan is established for all staff in order to satisfy/fulfil the needs identified. Training
activities are performed and recorded by the NRA.


Ref:
02.05.05 The development policy and plan have been established for the implementation of the quality management system for all regulatory functions.


Ref:
RA06.11: Commitment, policy statement and development plan to implement a quality management system relevant to all regulatory functions.


Ref:
03.03.04 Action plans are established and implemented to achieve the objectives set.


Ref:
02.05.04 The quality policy and objectives are defined and documented.


Ref:
RS04.01: Commitment, policy statement and development plan to implement a quality management system relevant to all regulatory functions.


Ref:
RA08.02: Code of conduct including management of conflicts of interest is published and enforced


Ref:
RA06.05: Defined organizational chart and responsibilities to implement the Quality Management System


Ref:
02.04.01. A QMS is implemented by the NRA for all its core functions as specified below


Ref:
03.05.02 The NRA’s top management is committed to the development and implementation of the Quality
Management System in particular by providing financial and organizational support.


Ref:
02.04.02. Budgetary provisions are made for implementation and maintenance of the QMS


Ref:
RS04.02: Financial support to implement a quality management system


Ref:
02.08.08 There is a written mechanism to handle potential conflicts of interest of internal or external experts and committee members, to gather declarations of interest and guarantee the update of these declarations for all regulatory functions.


Ref:
03.08.06 There is a general policy on potential conflicts of interest for external experts and members of
advisory committees.


Ref:
02.03.05. Policies and procedures exist for recruitment and selection of external experts and the management of expert advisory committees, including potential conflict of interest


Ref:
03.07.09 A documented mechanism is in place to evaluate the impact and to demonstrate the effectiveness of the training activities.


Ref:
RA08.05: A mechanism is implemented that records and Monitors acquired skills and or competencies of the staff after training including the impact on relevant functionality.


Ref:
02.07.09 The NRA performs and maintains records of staff training activities. A mechanism is established to evaluate and demonstrate the effectiveness of training activities.


Ref:
RA06.03: The NRA has established policy and requirements for records retention in line with the public administration rules and product life cycle.


Ref:
03.05.11 The corrective and preventive actions taken as a result of audits or from other non conformities
are implemented and documented. Their efficacy is checked and documented.


Ref:
02.05.12 Corrective and preventive actions taken as a result of audits or nonconformities are implemented and documented and their effectiveness is verified.


Ref:
RA06.10: Corrective and preventive actions decided (as a result of audit or for any other reasons) are implemented, monitored and evaluated. All documentation and records are maintained.


Ref:
02.04.07. An internal and external audit and review system exists as well as evidence that corrective and preventive actions are taken as a result of monitoring and/or audits


Ref:
RA17.01: The regulatory institutions activities are regularly and systematically reviewed through an audit mechanism to identify gaps and strengths.


Ref:
03.05.10 Internal audits of the complete QMS are done at least once every 12 months. Records of the
results are maintained.


Ref:
02.04.04. The documentation needed to establish, implement and maintain the QMS is defined (quality manual, SOPs, etc


Ref:
02.05.09 The documentation required by the quality management system (QMS) is controlled by following a written procedure.


Ref:
03.05.08 The documentation required by the QMS is controlled following a documented procedure.


Ref:
RA06.04: The NRA has identified all the processes related to its regulatory activities , established their interactions and devised methods to check their implementation and efficacy.


Ref:
03.05.06 The NRA has identified its processes for each regulatory function, determined their interactions
and methods needed to control these processes.


Ref:
RA06.07: Traceability needs are identified within the NRA. Documented procedures are implemented to ensure traceability of the regulatory activities.


Ref:
02.03.04. Mechanisms are in place to ensure that those performing regulatory functions have sufficient and current expertise in specialized areas


Ref:
02.07.05 The NRA has the power to select and recruit its own staff, following a documented procedure based on its own written criteria (experience, minimal education, high-level training, etc.).


Ref:
03.07.05 The NRA is able to select and recruit its own staff following documented procedures based on its
own written criteria (experience, minimum educational background, advanced training, etc.).


Ref:
03.08.04 There is a written policy / procedure for the recruitment and the designation of external experts and members of experts committees calling for candidates, defining the review by a selective jury


Ref:
02.08.04 There is a written policy/procedure for appointment and recruitment of external experts, defining the selection of candidates by a selection and appointment panel/jury and making the final decision public.


Ref:
RA08.04: An initial and periodic staff appraisal system is established to review performance and competencies, identify academic and training needs and agree on performance targets.


Ref:
02.07.06 An initial period for staff evaluation is established to review performance, identify training needs and establish agreements on the objectives to be developed.


Ref:
RA10.02: Documented procedures are implemented by the NRA to control the purchasing of products (and services) and their verification.


Ref:
RA08.01: The duties, functions, responsibilities, necessary competencies and specific policies, as per the organogram, are established in the respective job descriptions.


Ref:
03.07.01 An organization Chart / organigram for the NRA staff is established and updated.


Ref:
03.07.02 The NRA’s key technical and scientific personnel have been identified based on their authorities
and responsibilities.


Ref:
03.07.03 The duties, functions and responsibilities of the key personnel are established in the respective
job descriptions.


Ref:
02.07.01 There is an organizational chart of the structure of the NRA.


Ref:
02.07.02 The key staff of the NRA are identified.


Ref:
02.07.03 The obligations, roles and responsibilities of key staff are established in the job descriptions.


Ref:
02.07.04 The NRA has established the necessary skills (education, training, qualifications and experience) for key staff to perform the assigned work.


Ref:
02.03.02. All staff members have appropriate qualifications to conduct regulatory activities and are provided with timely, relevant and regularly updated training


Ref:
02.03.03. Tasks and responsibilities of staff members are well defined


# Reg_fun_tbl_data

element:
RS01 Legal provisions, regulations and guidelines required to define regulatory framework of national regulatory system


element:
RS02 Arrangement for effective organization and good governance


element:
RS03 Strategeic Plan with clarified Objective in Place


element:
RS04 Plans for crisis management, backed up with talented leaders


element:
RS05 Mechanism exist to promote transparency, accountability and communication


element:
RS06 Mechanism in place to monitor regulatory performance and output


element:
RS07 Financial resources to perform regulatory activities


element:
RS08 Infrastructure and equipment to perform regulatory activities


element:
RS09 Quality Management Systems including the risk management principles are applied and realised


element:
RS10 Human resources to perform regulatory activities


# Temp_Reg_fun_tbl_data

element:
RS01: Legal framework for establishment of a regulatory system, mandate and enforcement power for each function


element:
RS06: Strategic or and detailed Institutional development plan


element:
RS05: Transparency and public accountability


element:
RS04: Total quality management system for all the relevant regulatory functions


element:
RS03: Recall system with mechanism to ensure proper disposition/disposal of affected lots


element:
RS02: Independence of the regulatory authority in decision making


element:
RS07: Advisory  and or experts committees


# VacSource

VaccineSourceName:
National Center for Infectious Disease. BB-NCIPD Ltd.


VaccineSourceName:
Centers for Disease Control and Prevention


VaccineSourceName:
Chengdu Institute of Biological Products


VaccineSourceName:
Centro de Ingeniería Genética y Biotecnología  


VaccineSourceName:
Gamaleya Institute of Epidemiology and Microbiology


VaccineSourceName:
Human Serum Production & Medecine Manufacturing Co.


VaccineSourceName:
Human Institute for Serobacteriological Production and Research


VaccineSourceName:
Instituto Nacional de Higiene "Rafael Rangel"


VaccineSourceName:
Instituto Nacional de Higiene y Medicina Tropical “Leopoldo Izquieta Pérez”


VaccineSourceName:
Chumakov Institute of Poliomyelitis and Viral Encephalitides (IPVE)  


VaccineSourceName:
Irkutsk Federal State Unitary Enterprise


VaccineSourceName:
Institute of Vaccines and Medical Biologicals


VaccineSourceName:
National Institute of Hygiene and Epidemiology         


VaccineSourceName:
Novartis Vaccines and Diagnostics GmbH & Co. KG


VaccineSourceName:
Novartis Vaccines and Diagnostics S.r.l.


VaccineSourceName:
Torlak Institute of Virology Vaccines and Sera


VaccineSourceName:
The Reasearch foundation for Microbial Diseases of Osaka University


