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What is PIC/S GMP?

15/09/2021 | 4211

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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system.

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 ries 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 ries to be admitted as members of PIC. European law did not permit individual EU ries that were members of PIC to sign agreements with other ries 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 ries. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995.

LIST OF PIC/S PARTICIPATING AUTHORITIES

The following are the state members of PIC/S as of May 2020

Country Participating entity Accession to PIC Scheme
 Argentina Instituto Nacional de Medicamentos (INAME) 2008
 Australia Therapeutic Goods Administration (TGA) 1995
 Austria Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES) 1999
 Belgium Federal Agency for Medicines and Health Products (FAGG) 1997
 Canada Health Canada's Regulatory Operations and Enforcement Branch (ROEB) 1999
 Chinese Taipei Food and Drug Administration (TFDA) 2013
 Croatia Agencija za lijekove i medicinske proizvode (HALMED) 2016
 Cyprus Pharmaceutical Services (CyPHS) 2008
 Czech Republic State Institute for Drug Control (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 Agence nationale de sécurité du médicament et des produits de santé (ANSM)
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)
1997
2009
 Germany Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) 2000
 Greece Greek National Organisation for Medicines (EOF) 2002
 Hong Kong SAR Pharmacy and Poisons Board of Hong Kong (PPBHK) 2016
 Hungary National Institute of Pharmacy and Nutrition (NIPN) 1995
 Iceland Icelandic Medicines Agency (IMA) 1995
 Indonesia National Agency for Drug and Food Control (NADFC) 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 (AIFA)
Direzione generale della sanità animale e dei farmaci veterinari (DGSAF)
2000
2020
 Japan Pharmaceuticals and Medical Devices Agency (PMDA) 2014
 Latvia Zāļu valsts aģentūra (ZVA) 2004
 Liechtenstein Amt für Gesundheit (AG) 1995
 Lithuania State Medicines Control Agency (SMCA) 2009
 Malaysia National Pharmaceutical Regulatory Agency (NPRA) 2002
 Malta Malta Medicines Authority (MMA) 2008
 Mexico Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) 2018
 Netherlands Health and Youth Care Inspectorate 1995
 New Zealand Medicines and Medical Devices Safety Authority (Medsafe) 2013
 Norway Norwegian Medicines Agency (NOMA) 1995
 Poland Chief Pharmaceutical Inspectorate (CPI) 2006
 Portugal 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 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 (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

Future members

 Brazil National Sanitary Surveillance Agency (Anvisa) 2021

 

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  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
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  • Contact
 
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