PIC/S Guide- A Comprehensive Review

PIC/S guide
PIC/S guide

It contains History of PIC, PIC/S Guide, FAQs and List of PICs Members.

History Of PIC/S Guide:

In October 1970, the Pharmaceutical Inspection Convention (PIC) was established by the European Free Trade Association (EFTA) as the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. Originally, the PIC consisted of the 10 EFTA member countries. However, in the 1990s, it was discovered that the Convention and European law were incompatible, making it impossible for new countries to join the PIC. To address this issue, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) was formed on 2 November 1995 as an informal agreement between health authorities. The PIC/S and PIC operate in parallel and are jointly referred to as PIC/S.

In short The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to Pharmaceutical Inspection Convention (PIC) of 1970.

The PIC/S is meant as a media to improve co-operation in the field of Good Manufacturing Practices between Regulatory Authorities  and the Pharmaceutical industries.


Below are Two Common Questions about GMP certificates / Regulatory Inspections for PIC/S Countries :

 Do PIC/S Members Recognize GMP Certificates from other PIC/S Members?PICS Guide

Do non-PIC/S Members Recognize GMP Certificates from PIC/S Members?

PICS Guide





Presently PIC/S Having 51 members that are as Below :

1. Argentina :-  National Institute of Drugs
                          Instituto Nacional de Medicamentos (INAME)

2. Australia  :-    Therapeutic Goods Administration (TGA)

3. Austria    :-     Federal Office for Safety in Health Care 
Bundesamt für Sicherheit im Gesundheitswesen (BASG)

4. Belgium   :-     Federal Agency for Medicines and Health Products
Agence Fédérale des Médicaments et des Produits de Santé (AFMPS)
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)

5.Brazil        :-      National Health Surveillance Agency (ANVISA)
                             Agência Nacional de Vigilância Sanitária (ANVISA)

6.CanadaHealth Canada / Santé Canada

               Regulatory Operations and Enforcement Branch (ROEB)
               Direction générale des opérations réglementaires et de l’application de la loi (DGORAL)

7.Chinese Taipei – Taiwan Food and Drug Administration (TFDA)

Croatia –  Agency for Medicinal Products and Medical Devices of Croatia
                Agencija za lijekove i medicinske proizvode (HALMED)

Cyprus –  Pharmaceutical Services (CyPHS)

Czech Republic –  State Institute for Drug Control
                             Státní Ústav pro Kontrolu Léčiv (SÚKL)

Denmark –  Danish Medicines Agency (DKMA)

Estonia – State Agency of Medicines (SAM)

Finland – Finnish Medicines Agency (FIMEA)

France – French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)

Germany – Federal Ministry of Health *
                Bundesministerium für Gesundheit (BMG)

Greece – Greek National Organisation for Medicines
              Εθνικός Οργανισμός Φαρμάκων (EOF)

Hong Kong SAR-  Pharmacy and Poisons Board of Hong Kong (PPBHK)

Hungary – National Institute of Pharmacy and Nutrition (NIPN)

Iceland –  Icelandic Medicines Agency (IMA)

Indonesia – Indonesian Food and Drug Authority (Badan POM)
                  (Badan Pengawas Obat dan Makanan Republik Indonesia)

Iran –  Iran Food and Drug Administration (IFDA)

Israel – Institute for Standardization and Control of Pharmaceuticals (ISCP)

Italy – Italian Medicines Agency 
         Agenzia Italiana del Farmaco (AIFA)

Japan –  Pharmaceuticals and Medical Devices Agency (PMDA)

Korea (Republic of) – Ministry of Food and Drug Safety (MFDS)

Latvia – State Agency of Medicines
             Zāļu valsts aģentūra (ZVA)

Liechtenstein – Office of Healthcare
                     Amt für Gesundheit (AG

Lithuania – State Medicines Control Agency (SMCA)

Malaysia – National Pharmaceutical Regulatory Agency (NPRA)

Malta – Malta Medicines Authority (MMA)

Mexico – Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)
              Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

Netherlands – Health and Youth Care Inspectorate 
                      Inspectie Gezondheidszorg en Jeugd  (IGJ)

New Zealand – Medicines and Medical Devices Safety Authority (Medsafe)

Norway – Norwegian Medicines Agency (NOMA)

Poland – Chief Pharmaceutical Inspectorate (CPI)

Portugal –  National Authority of Medicines and Health Products, IP
                 Autoridade Nacional do Medicamento e Produtos de Saúde IP (INFARMED IP )

Romania – National Agency for Medicines and Medical Devices of Romania  (NAMMDR)

Singapore – Health Sciences Authority (HSA)

Slovak Republic – State Institute for Drug Control (SIDC)

Slovenia –  Agency for Medicinal Products and Medical Devices
                  Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)

South Africa –  South African Health Products Regulatory Authority (SAHPRA)

Spain – Spanish Agency of Medicines and Medical Devices*
            Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

Sweden – Swedish Medical Products Agency (MPA)

Switzerland – Swiss Agency for Therapeutic Products (Swissmedic)

Thailand – Food and Drug Administration (Thai FDA)

Turkey – Turkish Medicines and Medical Devices Agency (TMMDA)

Ukraine – State Service of Ukraine on Medicines and Drugs Control (SMDC)

United Kingdom – Medicines & Healthcare Products Regulatory Agency (MHRA)

U.S.A –    U.S. Food and Drug Administration (US FDA)








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