Regulatory authorities for different countries

Global Pharmacovigilance laws and regulations – IAOCR Directory

  • Serbia – Medicines and Medical Devices Agency of Serbia
  • Slovakia – State Institute for Drug Control
  • Slovenia – Ministry of Health
  • Spain – Spanish Medicines Agency
  • Sweden – Medical Products Agency
  • Switzerland – Swiss Agency for Therapeutic Products
  • Ukraine – Ministry of Health
  • United Kingdom – Medicines and Healthcare Regulatory Agency (MHRA)
  • Bahrain – I-SEHA
  • Egypt – Ministry of Health
  • Iran – Ministry of Health
  • Israel – Ministry of Health
  • Jordan – Jordan Food and Drug Administration
  • Lebanon – Ministry of Public Health
  • Saudi Arabia – Saudi Food and Drug Authority
  • United Arab Emirates – Ministry of Health
  • Bangladesh – Directorate General of Drug Administration (DGDA)
  • Bhutan – Drug Regulatory Authority
  • China* – CFDA/NMPA: State Food and Drug Administration
  • India – Central Drug Standards Control Organization (CDSCO)
  • Indonesia – POM (Pengawas Obat dan Makanan)
  • JAPAN* – PMDA: Ministry of Health, Labour and Welfare ~12%
  • Korea (South) – Korean Food and Drug Administration (KFDA) ~1%
  • Laos – Food and Drug Department
  • Malaysia – Ministry of Health (MOH)
  • Nepal – Department of Drug Administration
  • Philippines – Department of Health (DOH)
  • Singapore – Health Sciences Authority (HSA)
  • Sri Lanka – Ministry of Health (MOH)
  • Taiwan (Republic of China) – Taiwan Food and Drug Administration (TFDA)
  • Thailand – Food and Drug Administration of Thailand
  • Vietnam – Drug Administration of Vietnam
  • Algeria – Ministry of Health and Population
  • Botswana – Ministry of Health (MOH)
  • Burkina Faso – Le Ministère de la Santé
  • Ghana – Food and Drugs Authority
  • Kenya – Pharmacy and Poisons Board
  • Morocco – Ministry of Health
  • Nigeria – National Agency for Food and Drug Administration and Control
  • Rwanda – Ministry of Health
  • Senegal – Ministère de la Santé et de l’Action Sociale
  • South Africa – Medicines Control Council (MCC)
  • Swaziland – Ministry of Health
  • Tanzania – Tanzania Food and Drug Authority (TFDA)
  • Uganda – National Drug Authority

Local Pharmacovigilance Regulatory Bodies

  • Australia – Therapeutic Goods Administration (TGA)
  • New Zealand – MEDSAFE
  • North America
  • Canada – Health Canada ~2%
  • USA* – FDA: Food and Drug Administration ~33%
  • Central/South America
  • Argentina – ANMAT
  • Brazil – Agencia Nacional de Vigilancia Sanitaria (ANVISA)
  • Chile – Instituto de Salud Publico (ISP)
  • Columbia – Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)
  • Costa Rica – Ministerio de Salud
  • Cuba – CECMED
  • Dominican Republic – Dirección General de Drogas y Farmacias
  • Jamaica – Ministry of Health
  • Mexico – Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
  • Paraguay – Ministro de Salud Pública y Bienestar Social
  • Peru – Ministerio de Salud
  • Uruguay – Ministerio de Salud Publica
  • European Union* – EMA: European Medicines Agency ~17%
  • Armenia – Scientific Centre of Drug and Medical Technology Expertise
  • Austria – Agency for Health and Food Safety (AGES)
  • Belgium – Federal Agency for Medicines and Health Products
  • Bulgaria – Bulgarian Drug Agency
  • Croatia – Agency for Medicinal Products and Medical Devices of Croatia
  • Cyprus – Ministry of Health
  • Czech Republic – State Institute for Drug Control
  • Denmark – Danish Medicines Agency
  • Estonia – State Agency of Medicines
  • Finland – Finish Medicines Agency
  • France – Agence Nationale de Sécurité du Medicament et des Produits de Santé
  • Germany – Federal Institute for Drugs and Medical Devices
  • Georgia – Regulation Agency for Medical and Pharmaceutical Activities
  • Greece – National Organisation for Medicines
  • Hungary – National Institute of Pharmacy
  • Iceland – Icelandic Medicines Agency
  • Ireland – Irish Medicines Board
  • Italy – National Institute of Health
  • Lithuania – State Medicines Control Agency
  • Luxembourg – Ministry of Health
  • Malta – Maltese Medicines AuthorityMoldova – Medicines Agency
  • Netherlands – Medicines Evaluation Board
  • Norway – Norwegian Medicines Agency
  • Poland – The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • Portugal – National Authority of Medicines and Health Products
  • Romania – National Medicines Agency
  • Russia – Ministry of Health of the Russian Federation

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