The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.
History The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with other countries seeking to join PIC. As a consequence the Pharmaceutical Inspection Co-operation Scheme was formed on 2 November 1995. The Pharmaceutical Inspection Co-operation Scheme is an informal agreement between health authorities instead of a formal treaty between countries. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995.
Since its conception until 2003, PIC/S did not have a distinct legal identity. Its Secretariat was provided by the European Free Trade Association. Based on PIC/S meeting in June 2003, its committee decided to constitute itself as a Swiss Association in accordance with article 60 of the Swiss Civil Code which refer to other internationally active organizations established in Switzerland such as the International Committee of the Red Cross (ICRC). On 1 January 2004, PIC/S established its own Secretariat in Geneva, Switzerland.
Purpose PIC/S has a number of provisions intended to establish the following:
Mutual recognition of inspection between member countries, so that an inspection carried out by officials of one member country will be recognized as valid by other members. Equivalent principles of inspection methodology, so that it is understood that inspectors in each member country will be following the same best practices when carrying out inspections. Mechanisms for the training of inspectors. Harmonization of written standards of Good Manufacturing Practices. Lines of communication between member country inspectors/inspectorates.
Members
The following are the state members of PIC/S as of October 2021:
Country Participating entity Accession to PIC Scheme National Institute of DrugsInstituto Nacional de Medicamentos (INAME) 2008 Therapeutic Goods Administration (TGA) 1995 Federal Office for Safety in Health CareBundesamt für Sicherheit im Gesundheitswesen (BASG) 1999 Federal Agency for Medicines and Health ProductsAgence Fédérale des Médicaments et des Produits de Santé (AFMPS)Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) 1997 National Health Surveillance AgencyAgência Nacional de Vigilância Sanitária (ANVISA) 2021 Health Canada's Regulatory Operations and Enforcement Branch (ROEB)Santé Canada Direction générale des opérations réglementaires et de l'application de la loi (DGORAL) 1999 Food and Drug Administration (TFDA) 2013 Agency for Medicinal Products and Medical Devices of CroatiaAgencija za lijekove i medicinske proizvode (HALMED) 2016 Pharmaceutical Services (CyPHS) 2008 State Institute for Drug ControlStátní Ústav pro Kontrolu Léčiv (SÚKL)Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM) 19972005 Danish Medicines Agency (DKMA) 1995 State Agency of Medicines (SAM) 2007 Finnish Medicines Agency (FIMEA) 1996 French National Agency for Medicines and Health Products SafetyAgence nationale de sécurité du médicament et des produits de santé (ANSM)Agency for Food, Environmental & Occupational Health SafetyAgence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES) 19972009 Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical DevicesZentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) 2000 Greek National Organisation for MedicinesΕθνικός Οργανισμός Φαρμάκων (EOF) 2002 Pharmacy and Poisons Board of Hong Kong (PPBHK) 2016 National Institute of Pharmacy and Nutrition (OGYÉI) 1995 Icelandic Medicines Agency (IMA) 1995 National Agency for Drug and Food Control (NADFC)Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM) 2012 Iran Food and Drug Administration (IFDA) 2018 Health Products Regulatory Authority (HPRA) 1996 Institute for Standardization and Control of Pharmaceuticals (ISCP) 2009 Italian Medicines AgencyAgenzia Italiana del Farmaco (AIFA)Directorate General for Animal Health and Veterinary Medicinal ProductsDirezione generale della sanità animale e dei farmaci veterinari (DGSAF) 20002020 Pharmaceuticals and Medical Devices Agency (PMDA) 2014 State Agency of MedicinesZāļu valsts aģentūra (ZVA) 2004 Office of HealthcareAmt für Gesundheit (AG) 1995 State Medicines Control Agency (SMCA) 2009 National Pharmaceutical Regulatory Agency (NPRA)Bahagian Regulatori Farmasi Negara 2002 Malta Medicines Authority (MMA) 2008 Federal Commission for the Protection against Sanitary RiskComisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) 2018 Health and Youth Care InspectorateInspectie Gezondheidszorg en Jeugd (IGJ) 1995 Medicines and Medical Devices Safety Authority (Medsafe) 2013 Norwegian Medicines Agency (NOMA) 1995 Chief Pharmaceutical Inspectorate (CPI) 2006 National Authority of Medicines and Health Products, IPAutoridade Nacional do Medicamento e Produtos de Saúde IP (INFARMED IP ) 1999 National Agency for Medicines and Medical Devices (NAMMD) 1995 Health Sciences Authority (HSA) 2000 State Institute for Drug Control (SIDC) 1997 Agency for Medicinal Products and Medical DevicesJavna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) 2012 South African Health Products Regulatory Authority (SAHPRA) 2007 Ministry of Food and Drug Safety (MFDS) 2014 Spanish Agency of Medicines and Medical DevicesAgencia Española de Medicamentos y Productos Sanitarios (AEMPS) 1998 Swedish Medical Products Agency (MPA) 1996 Swiss Agency for Therapeutic Products (Swissmedic) 1996 Food and Drug Administration (Thai FDA) 2016 Turkish Medicines and Medical Devices Agency (TMMDA) 2018 State Service for Medications and Drugs Control (SMDC) 2011 Medicines and Healthcare products Regulatory Agency (MHRA) Veterinary Medicines Directorate (VMD) 19992014 U.S. Food and Drug Administration (USFDA) 2011
See also GxP Good automated manufacturing practice (GAMP) Corrective and preventive action (CAPA) Validation (drug manufacture) European Medicines Agency (EMEA) European Federation of Pharmaceutical Industries and Associations (EFPIA) Pharmaceutical Research and Manufacturers of America (PhRMA)
References
External links
European Federation of Pharmaceutical Industries and Associations (EFPIA) Japan Pharmaceutical Manufacturers Association (JPMA) Pharmaceutical Research and Manufacturers of America (PhRMA)