 Logo of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme | |
| Abbreviation | PIC/S |
|---|---|
| Formation | 26 May 1971 |
| Type | Intergovernmental organization |
| Purpose | Pharmaceutical |
| Headquarters | Geneva, Switzerland |
| Coordinates | 46°12′18″N 6°09′30″E / 46.2050823°N 6.158363°E |
Area served | International |
Membership | 52 Active state members |
| Website |
www |
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 |
|---|---|---|
Argentina |
National Institute of Drugs Instituto Nacional de Medicamentos (INAME) |
2008 |
Australia |
Therapeutic Goods Administration (TGA) | 1995 |
Austria |
Federal Office for Safety in Health Care Bundesamt für Sicherheit im Gesundheitswesen (BASG) |
1999 |
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 |
Brazil |
National Health Surveillance Agency Agência Nacional de Vigilância Sanitária (ANVISA) |
2021 |
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 |
Chinese Taipei |
Food and Drug Administration (TFDA) | 2013 |
Croatia |
Agency for Medicinal Products and Medical Devices of Croatia Agencija za lijekove i medicinske proizvode (HALMED) |
2016 |
Cyprus |
Pharmaceutical Services (CyPHS) | 2008 |
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 |
Denmark |
Danish Medicines Agency (DKMA) | 1995 |
Estonia |
State Agency of Medicines (SAM) | 2007 |
Finland |
Finnish Medicines Agency (FIMEA) | 1996 |
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 |
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 |
Greece |
Greek National Organisation for Medicines Εθνικός Οργανισμός Φαρμάκων (EOF) |
2002 |
Hong Kong SAR |
Pharmacy and Poisons Board of Hong Kong (PPBHK) | 2016 |
Hungary |
National Institute of Pharmacy and Nutrition (OGYÉI) | 1995 |
Iceland |
Icelandic Medicines Agency (IMA) | 1995 |
Indonesia |
National Agency for Drug and Food Control (NADFC) Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM) |
2012 |
Iran |
Iran Food and Drug Administration (IFDA) | 2018 |
Ireland |
Health Products Regulatory Authority (HPRA) | 1996 |
Israel |
Institute for Standardization and Control of Pharmaceuticals (ISCP) | 2009 |
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 |
Japan |
Pharmaceuticals and Medical Devices Agency (PMDA) | 2014 |
Latvia |
State Agency of Medicines Zāļu valsts aģentūra (ZVA) |
2004 |
Liechtenstein |
Office of Healthcare Amt für Gesundheit (AG) |
1995 |
Lithuania |
State Medicines Control Agency (SMCA) | 2009 |
Malaysia |
National Pharmaceutical Regulatory Agency (NPRA) Bahagian Regulatori Farmasi Negara |
2002 |
Malta |
Malta Medicines Authority (MMA) | 2008 |
Mexico |
Federal Commission for the Protection against Sanitary Risk Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) |
2018 |
Netherlands |
Health and Youth Care Inspectorate Inspectie Gezondheidszorg en Jeugd (IGJ) |
1995 |
New Zealand |
Medicines and Medical Devices Safety Authority (Medsafe) | 2013 |
Norway |
Norwegian Medicines Agency (NOMA) | 1995 |
Poland |
Chief Pharmaceutical Inspectorate (CPI) | 2006 |
Portugal |
National Authority of Medicines and Health Products, IP Autoridade Nacional do Medicamento e Produtos de Saúde IP (INFARMED IP ) |
1999 |
Romania |
National Agency for Medicines and Medical Devices (NAMMD) | 1995 |
Singapore |
Health Sciences Authority (HSA) | 2000 |
Slovakia |
State Institute for Drug Control (SIDC) | 1997 |
Slovenia |
Agency for Medicinal Products and Medical Devices Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) |
2012 |
South Africa |
South African Health Products Regulatory Authority (SAHPRA) | 2007 |
South Korea |
Ministry of Food and Drug Safety (MFDS) | 2014 |
Spain |
Spanish Agency of Medicines and Medical Devices Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) |
1998 |
Sweden |
Swedish Medical Products Agency (MPA) | 1996 |
Switzerland |
Swiss Agency for Therapeutic Products (Swissmedic) | 1996 |
Thailand |
Food and Drug Administration (Thai FDA) | 2016 |
Turkey |
Turkish Medicines and Medical Devices Agency (TMMDA) | 2018 |
Ukraine |
State Service for Medications and Drugs Control (SMDC) | 2011 |
United Kingdom |
Medicines and Healthcare products Regulatory Agency (MHRA) Veterinary Medicines Directorate (VMD) |
1999 2014 |
United States |
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
- ^ "History of PIC/S". picscheme.org. Retrieved 2 October 2021.
- ^ a b Brunner, Daniel (September 2004). "Pharmaceutical Inspection Co-operation Scheme (PIC/S)". The Quality Assurance Journal. 8 (3): 207–211. doi: 10.1002/qaj.281.
- ^ "Legal Form". picscheme.org. Retrieved 2 October 2021.
- ^ McCormick, Kate (2002). Quality (Pharmaceutical Engineering Series). Butterworth-Heinemann. p. 158. ISBN 9780750651134.
- ^ "Members". www.picscheme.org. Retrieved 2 October 2021.
External links
- Official website
- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Japan Pharmaceutical Manufacturers Association (JPMA)
- Pharmaceutical Research and Manufacturers of America (PhRMA)
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