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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.
 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 |
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 |
|---|---|---|
 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 | (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.
- 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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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 Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co operation SchemeLogo of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co operation SchemeAbbreviationPIC SFormation26 May 1971 53 years ago 1971 05 26 TypeIntergovernmental organizationPurposePharmaceuticalHeadquartersGeneva SwitzerlandCoordinates46 12 18 N 6 09 30 E 46 2050823 N 6 158363 E 46 2050823 6 158363Area servedInternationalMembership52 Active state membersWebsitewww wbr picscheme wbr orgHistoryThe 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 PurposePIC 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 MembersMap of the members of PIC S The following are the state members of PIC S as of October 2021 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 fur Sicherheit im Gesundheitswesen BASG 1999 Belgium Federal Agency for Medicines and Health Products Agence Federale des Medicaments et des Produits de Sante AFMPS Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten FAGG 1997 Brazil National Health Surveillance Agency Agencia Nacional de Vigilancia Sanitaria ANVISA 2021 Canada Health Canada s Regulatory Operations and Enforcement Branch ROEB Sante Canada Direction generale des operations reglementaires 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 Statni Ustav pro Kontrolu Leciv SUKL 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 securite du medicament et des produits de sante ANSM Agency for Food Environmental amp Occupational Health Safety Agence nationale de securite 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 Lander fur Gesundheitsschutz bei Arzneimitteln und Medizinprodukten ZLG 2000 Greece Greek National Organisation for Medicines E8nikos Organismos Farmakwn EOF 2002 Hong Kong SAR Pharmacy and Poisons Board of Hong Kong PPBHK 2016 Hungary National Institute of Pharmacy and Nutrition OGYEI 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 sanita animale e dei farmaci veterinari DGSAF 2000 2020 Japan Pharmaceuticals and Medical Devices Agency PMDA 2014 Latvia State Agency of Medicines Zalu valsts agentura ZVA 2004 Liechtenstein Office of Healthcare Amt fur Gesundheit AG 1995 Lithuania State Medicines Control Agency SMCA 2009 Malaysia NPRA Bahagian Regulatori Farmasi Negara 2002 Malta Malta Medicines Authority MMA 2008 Mexico Federal Commission for the Protection against Sanitary Risk Comision Federal para la Proteccion 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 Saude 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 pripomocke 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 Espanola 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 2011See alsoGxP 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 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 linksOfficial website European Federation of Pharmaceutical Industries and Associations EFPIA Japan Pharmaceutical Manufacturers Association JPMA Pharmaceutical Research and Manufacturers of America PhRMA This pharmacology related article is a stub You can help Wikipedia by expanding it vte