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    PICS Countries PDF

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    This document lists the participating authorities in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). It provides the names of 52 participating authorities from 38 countries/entities in alphabetical order, along with their acronyms. Some countries/entities have multiple participating authorities that are counted separately. The document also provides explanatory footnotes for certain participating authorities.

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    PICS Countries PDF

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    This document lists the participating authorities in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). It provides the names of 52 participating authorities from 38 countries/entities in alphabetical order, along with their acronyms. Some countries/entities have multiple participating authorities that are counted separately. The document also provides explanatory footnotes for certain participating authorities.

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    This document lists the participating authorities in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). It provides the names of 52 participating authorities from 38 countries/entities in alphabetical order, along with their acronyms. Some countries/entities have multiple participating authorities that are counted separately. The document also provides explanatory footnotes for certain participating authorities.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    182 views3 pages

    PICS Countries PDF

    Uploaded by

    Iss Shipper
    This document lists the participating authorities in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). It provides the names of 52 participating authorities from 38 countries/entities in alphabetical order, along with their acronyms. Some countries/entities have multiple participating authorities that are counted separately. The document also provides explanatory footnotes for certain participating authorities.

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    of 3

    PHARMACEUTICAL INSPECTION CONVENTION

    PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

    PS/INF 21/2002 (Rev. 23)


    31 January 2018

    LIST OF PIC/S PARTICIPATING AUTHORITIES

    (in the alphabetical order of the country / entity in which they are located)

    PARTICIPATING AUTHORITY ACRONYM


    Argentina Instituto Nacional de Medicamentos (National Institute INAME
    of Drugs)
    Australia Therapeutic Goods Administration TGA
    Austria Austrian Agency for Health and Food Safety AGES
    Belgium Agence Fédérale des Médicaments et des Produits de AFMPS
    Santé (Federal Agency for Medicines and Health
    Products)
    Canada Health Canada - Regulatory Operations and Regions RORB
    Branch (Santé Canada - Direction générale des
    opérations réglementaires et des régions)
    Chinese Taipei Taiwan Food and Drug Administration TFDA
    Croatia Agency for Medicinal Products and Medical Devices HALMED
    of Croatia (Agencija za lijekove i medicinske
    proizvode)
    Cyprus Pharmaceutical Services CyPHS
    Czech Republic 1
    Státní Ústav pro Kontrolu Léčiv (State Institute for SÚKL
    Drug Control)
    Ústav pro Státní Kontrolu Veterinárních Biopreparátů ISCVBM
    a Léčiv (Czech Institute for State Control of Veterinary
    Biologicals and Medicines)
    Denmark Danish Medicines Agency DKMA
    Estonia State Agency of Medicines SAM
    Finland Finnish Medicines Agency FIMEA
    France 2 Agence nationale de sécurité du médicament et des ANSM
    produits de santé (French National Agency for
    Medicines and Health Products Safety)
    Agence nationale de sécurité sanitaire de ANSES
    l'alimentation, de l'environnement et du
    travail (French Agency for Food, Environmental &
    Occupational Health Safety)

    1
    SÚKL and ÚSKVBL count as two distinct Participating Authorities.
    2
    ANSM and ANSES count as two distinct Participating Authorities.

    PS/INF 21/2002 (Rev. 23) 1 of 3 31 January 2018


    PARTICIPATING AUTHORITY ACRONYM
    Germany 3 Bundesministerium für Gesundheit (Federal Ministry BMG
    of Health)
    Zentralstelle der Länder für Gesundheitsschutz bei ZLG
    Arzneimitteln und Medizinprodukten (Central
    Authority of the Laender for Health Protection
    regarding Medicinal Products and Medical Devices)
    Greece Εθνικός Οργανισμός Φαρμάκων (National EOF
    Organization for Medicines)
    Hong Kong SAR Pharmacy and Poisons Board of Hong Kong PPBHK
    Hungary National Institute of Pharmacy and Nutrition (NIPN) NIPN
    Iceland The Icelandic Medicines Agency IMA
    Indonesia National Agency for Drug and Food Control NADFC
    Iran Iran Food and Drug Administration IFDA
    Ireland Health Products Regulatory Authority HPRA
    Israel Institute for the Standardization and Control of ISCP
    Pharmaceuticals
    Italy Agenzia Italiana del Farmaco AIFA
    Japan 4 Ministry of Health, Labour and Welfare MHLW
    Pharmaceuticals and Medical Devices Agency PMDA
    Japanese Prefectures -
    Korea (Republic of) Ministry of Food and Drug Safety MFDS
    Latvia Zāļu Valsts Aģentūra (State Agency of Medicines) ZVA
    Liechtenstein Amt für Gesundheit (Office of Healthcare) AG
    Lithuania State Medicines Control Agency SMCA
    Malaysia National Pharmaceutical Regulatory Agency NPRA
    Malta Medicines Authority Malta MAM
    Mexico Federal Commission for the Protection Against COFEPRIS
    Sanitary Risks (Comisión Federal para la Protección
    contra Riesgos Sanitarios)
    Netherlands Inspectie Gezondheidszorg en Jeugd (Health and IGJ
    Youth Care Inspectorate) 5
    New Zealand Medicines and Medical Devices Safety Authority Medsafe
    Norway Norwegian Medicines Agency NOMA

    3
    BMG and ZLG count as one Participating Authority. All German Medicinal Authorities, which
    are listed on the ZLG web site, are considered as PIC/S Participating Authorities and are represented in
    PIC/S by ZLG.
    4
    MHLW, PMDA and the Japanese Prefectures count as one Participating Authority. The
    Japanese Prefectures are represented by MHLW.
    5
    The competence for GMP/GDP inspections in the Netherlands is allocated to the central
    authority, Dutch Health and Youth Care Inspectorate (IGJ). IGJ is the PIC/S Participating Authority
    representing GMP/GDP for human as well as veterinary medicinal products. IGJ performs national and
    international GMP/GDP inspections representing the Health and Youth Care Inspectorate -
    Pharmaceutical Affairs as well as the Medicines Evaluation Board - Veterinary Medicinal Products Unit,
    which is mandated to issue GMP certificates on behalf of the Ministry of Economic Affairs.

    PS/INF 21/2002 (Rev. 23) 2 of 3 31 January 2018


    PARTICIPATING AUTHORITY ACRONYM
    Poland Chief Pharmaceutical Inspectorate CPI
    Portugal Autoridade Nacional do Medicamento e Produtos de INFARMED
    Saúde IP (National Authority of Medicines and Health IP
    Products IP)
    Romania National Agency for Medicines and Medical Devices NAMMD
    Singapore Health Sciences Authority HSA
    Slovak Republic State Institute for Drug Control SIDC
    Slovenia Agency for Medicinal Products and Medical Devices JAZMP
    South Africa Medicines Control Council MCC
    Spain Agencia Española de Medicamentos y Productos AEMPS
    Sanitarios (Spanish Agency for Medicines and Medical
    Devices) 6
    Sweden Medical Products Agency MPA
    Switzerland Swiss Agency for Therapeutic Products Swissmedic
    Thailand Food and Drug Administration Thai FDA
    Turkey Turkish Medicines and Medical Devices Agency TMMDA
    Ukraine State Service of Ukraine on Medicines and Drugs SMDC
    Control
    United Kingdom 7 Medicines and Healthcare Products Regulatory MHRA
    Agency
    Veterinary Medicines Directorate VMD
    United States of United States Food and Drug Administration US FDA
    America

    *******

    6
    The competence for GMP/GDP inspections in Spain is shared between the central authority,
    Spanish Agency for Medicines and Medical Devices (AEMPS), and the Spanish regional authorities,
    which count as one PIC/S Participating Authority. All Spanish Medicinal Authorities, which are listed on
    AEMPS’ web site, are considered as PIC/S Participating Authorities and are represented in PIC/S by
    AEMPS.
    7
    MHRA and VMD count as two distinct Participating Authorities.

    PS/INF 21/2002 (Rev. 23) 3 of 3 31 January 2018

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