Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
AbbreviationPIC/S
Formation26 May 1971 (53 years ago) (1971-05-26)
TypeIntergovernmental organization
PurposePharmaceutical
HeadquartersGeneva, Switzerland
Coordinates46°12′18″N 6°09′30″E / 46.2050823°N 6.158363°E / 46.2050823; 6.158363
Area served
International
Membership52 Active state members
Websitewww.picscheme.org

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

Map of the members of PIC/S

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

References

  1. ^ "History of PIC/S". picscheme.org. Retrieved 2 October 2021.
  2. ^ 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.
  3. ^ "Legal Form". picscheme.org. Retrieved 2 October 2021.
  4. ^ McCormick, Kate (2002). Quality (Pharmaceutical Engineering Series). Butterworth-Heinemann. p. 158. ISBN 9780750651134.
  5. ^ "Members". www.picscheme.org. Retrieved 2 October 2021.


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