PIC/S Guide- A Comprehensive Review

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?

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

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.Canada – Health 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)