Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
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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.[1][2] 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.[2]
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.[3]
Purpose
PIC/S has a number of provisions intended to establish the following:[4]
- 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:[5]
| Country | Participating entity | Accession to PIC Scheme |
|---|---|---|
| File:Flag of Argentina.svg Argentina | National Institute of Drugs Instituto Nacional de Medicamentos (INAME) |
2008 |
| File:Flag of Australia (converted).svg Australia | Therapeutic Goods Administration (TGA) | 1995 |
| File:Flag of Austria.svg Austria | Federal Office for Safety in Health Care Bundesamt für Sicherheit im Gesundheitswesen (BASG) |
1999 |
| File:Flag of Belgium (civil).svg 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) |
1997 |
| File:Flag of Brazil.svg Brazil | National Health Surveillance Agency Agência Nacional de Vigilância Sanitária (ANVISA) |
2021 |
| File:Flag of Canada (Pantone).svg Canada | 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 |
| File:Flag of Chinese Taipei for Olympic games.svg Chinese Taipei | Food and Drug Administration (TFDA) | 2013 |
| File:Flag of Croatia.svg Croatia | Agency for Medicinal Products and Medical Devices of Croatia Agencija za lijekove i medicinske proizvode (HALMED) |
2016 |
| File:Flag of Cyprus.svg Cyprus | Pharmaceutical Services (CyPHS) | 2008 |
| File:Flag of the Czech Republic.svg Czech Republic | State Institute for Drug Control Státní Ústav pro Kontrolu Léčiv (SÚKL) Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM) |
1997 2005 |
| File:Flag of Denmark.svg Denmark | Danish Medicines Agency (DKMA) | 1995 |
| File:Flag of Estonia.svg Estonia | State Agency of Medicines (SAM) | 2007 |
| File:Flag of Finland.svg Finland | Finnish Medicines Agency (FIMEA) | 1996 |
| File:Flag of France.svg France | French National Agency for Medicines and Health Products Safety Agence nationale de sécurité du médicament et des produits de santé (ANSM) Agency for Food, Environmental & Occupational Health Safety Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES) |
1997 2009 |
| File:Flag of Germany.svg Germany | Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) |
2000 |
| File:Flag of Greece.svg Greece | Greek National Organisation for Medicines Εθνικός Οργανισμός Φαρμάκων (EOF) |
2002 |
| Template:Country data Hong Kong SAR | Pharmacy and Poisons Board of Hong Kong (PPBHK) | 2016 |
| File:Flag of Hungary.svg Hungary | National Institute of Pharmacy and Nutrition (OGYÉI) | 1995 |
| File:Flag of Iceland.svg Iceland | Icelandic Medicines Agency (IMA) | 1995 |
| File:Flag of Indonesia.svg Indonesia | National Agency for Drug and Food Control (NADFC) Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM) |
2012 |
| File:Flag of Iran.svg Iran | Iran Food and Drug Administration (IFDA) | 2018 |
| File:Flag of Ireland.svg Ireland | Health Products Regulatory Authority (HPRA) | 1996 |
| File:Flag of Israel.svg Israel | Institute for Standardization and Control of Pharmaceuticals (ISCP) | 2009 |
| File:Flag of Italy.svg Italy | Italian Medicines Agency Agenzia Italiana del Farmaco (AIFA) Directorate General for Animal Health and Veterinary Medicinal Products Direzione generale della sanità animale e dei farmaci veterinari (DGSAF) |
2000 2020 |
| File:Flag of Japan.svg Japan | Pharmaceuticals and Medical Devices Agency (PMDA) | 2014 |
| File:Flag of Latvia.svg Latvia | State Agency of Medicines Zāļu valsts aģentūra (ZVA) |
2004 |
| File:Flag of Liechtenstein.svg Liechtenstein | Office of Healthcare Amt für Gesundheit (AG) |
1995 |
| File:Flag of Lithuania.svg Lithuania | State Medicines Control Agency (SMCA) | 2009 |
| File:Flag of Malaysia.svg Malaysia | National Pharmaceutical Regulatory Agency (NPRA) Bahagian Regulatori Farmasi Negara |
2002 |
| File:Flag of Malta.svg Malta | Malta Medicines Authority (MMA) | 2008 |
| File:Flag of Mexico.svg Mexico | Federal Commission for the Protection against Sanitary Risk Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) |
2018 |
| File:Flag of the Netherlands.svg Netherlands | Health and Youth Care Inspectorate Inspectie Gezondheidszorg en Jeugd (IGJ) |
1995 |
| File:Flag of New Zealand.svg New Zealand | Medicines and Medical Devices Safety Authority (Medsafe) | 2013 |
| File:Flag of Norway.svg Norway | Norwegian Medicines Agency (NOMA) | 1995 |
| File:Flag of Poland.svg Poland | Chief Pharmaceutical Inspectorate (CPI) | 2006 |
| File:Flag of Portugal.svg Portugal | National Authority of Medicines and Health Products, IP Autoridade Nacional do Medicamento e Produtos de Saúde IP (INFARMED IP ) |
1999 |
| File:Flag of Romania.svg Romania | National Agency for Medicines and Medical Devices (NAMMD) | 1995 |
| File:Flag of Singapore.svg Singapore | Health Sciences Authority (HSA) | 2000 |
| File:Flag of Slovakia.svg Slovakia | State Institute for Drug Control (SIDC) | 1997 |
| File:Flag of Slovenia.svg Slovenia | Agency for Medicinal Products and Medical Devices Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) |
2012 |
| File:Flag of South Africa.svg South Africa | South African Health Products Regulatory Authority (SAHPRA) | 2007 |
| File:Flag of South Korea.svg South Korea | Ministry of Food and Drug Safety (MFDS) | 2014 |
| File:Flag of Spain.svg Spain | Spanish Agency of Medicines and Medical Devices Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) |
1998 |
| File:Flag of Sweden.svg Sweden | Swedish Medical Products Agency (MPA) | 1996 |
| File:Flag of Switzerland (Pantone).svg Switzerland | Swiss Agency for Therapeutic Products (Swissmedic) | 1996 |
| File:Flag of Thailand.svg Thailand | Food and Drug Administration (Thai FDA) | 2016 |
| File:Flag of Turkey.svg Turkey | Turkish Medicines and Medical Devices Agency (TMMDA) | 2018 |
| File:Flag of Ukraine.svg Ukraine | State Service for Medications and Drugs Control (SMDC) | 2011 |
| File:Flag of the United Kingdom.svg United Kingdom | Medicines and Healthcare products Regulatory Agency (MHRA) Veterinary Medicines Directorate (VMD) |
1999 2014 |
| File:Flag of the United States.svg United States | U.S. Food and Drug Administration (USFDA) | 2011 |
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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
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External links
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- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Japan Pharmaceutical Manufacturers Association (JPMA)
- Pharmaceutical Research and Manufacturers of America (PhRMA)