Regulatory Resources

International Regulatory, Standards, and Harmonization Organizations

• ANDEAN Community
• International Coalition of Medicines Regulatory Authorities
• International Conference on Harmonisation (ICH)
• IPEC Federation
• International Generic Drug Regulators Programme
• International Medical Device Regulators Forum
• International Organization for Standardization (ISO)
• International Pharmaceutical Regulators Forum (IPRF)
• Organisation for Economic Co-operation and Development (OECD): Good Laboratory Practice (GLP)
• Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
• United Nations - Global Health
• World Health Organization (WHO)
• World Intellectual Property Organization (WIPO)

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Regional & National Regulatory Authorities

Africa

• Algeria: Directorate of Pharmacy and Medicine
• Botswana: Ministry of Health
• Egypt: Egyptian Drug Authority
• Ghana: Food and Drugs Authority
• Kenya: Pharmacy & Poisons Board
• Morocco: Ministry of Health (French)
• Namibia: Namibia Medicines Regulatory Council
• South Africa: Medicines Control Council
• Sudan: National Medicines and Poisons Board
• Tanzania Food and Drugs Authority
• Tunisia: Directorate of Pharmacy and Medicine
• Uganda: National Drug Authority
• Zimbabwe: Medicines Control Authority of Zimbabwe

Asia - Pacific

• Regional/Harmonization Organizations
  • ASIAN Harmonization Working Party (AHWP)
  • Asia Pacific Economic Cooperation (APEC)
  • Association of Southeast Asian Nations (ASEAN)
• National Authorities
  • Bangladesh: Directorate General of Drug Administration (DGDA)
  • Brunei Darussalam: Ministry of Health
  • China: China Food and Drug Administration
  • Hong Kong: Drug Office, Department of Health
  • India: Central Drugs Standard Control Organization (CDSCO)
  • Indonesia: The National Agency of Drug and Food Control
  • Republic of Korea: Ministry of Food and Drug Safety, Korea Food and Drug Administration
  • Malaysia: National Pharmaceutical Control Bureau
  • Mongolia: Ministry of Health
  • Nepal: Department of Drug Administration
  • Philippines: Department of Health, Philippine Food and Drug Administration
  • Singapore: Health Sciences Authority (HSA), Health Products Regulation Group (HPRG)
  • Sri Lanka: Ministry of Health
  • Taiwan Food and Drug Administration (TDFA)
  • Thailand: Food and Drug Administration
  • Vietnam: Drug Administration of Vietnam

Australia - New Zealand

• Regional/Harmonization Organization
  • Australia New Zealand Therapeutic Product Agency (ANZTPA)
• Australia
  • Australia: Therapeutic Goods Administration (TGA)
  • Australian Department of Health: Expert Review of Medicines and Medical Devices Regulation
• New Zealand
  • New Zealand: Medicines and Medical Devices Safety Authority

Europe

• Regional/Harmonization Organizations
  • European Medicines Agency (EMA)
  • European Heads of Medicines Agencies
  • European Directorate for the Quality of Medicines& Healthcare
  • European Commission: Medicinal products for human use
• National Authorities
  • Armenia: Scientific Centre of drug and medical technology expertise
  • Austria: Austrian Agency for Health and Food Safety
  • Azerbaijan: Azerbaijan Ministry of Health
  • Belarus: Center for Examinations and Tests in Health Service
  • Belgium: Federal Agency for Medicines and Health Products (FAMHP)
  • Bulgaria: Bulgarian Drug Agency
  • Croatia: Agency for Medicinal Products and Medical Devices of Croatia
  • Czech Republic - State Institute for Drug Control
  • Denmark: Danish Medicines Authority
  • Estonia - State Agency of Medicines
  • Finland - Finnish Medicines Agency
  • France - French National Agency for the Safety of Medicine Health Products (ANSM)
  • Germany: Federal Institute for Drugs and Medical Devices (BfArM)
  • Greece: National Organization for Medicines
  • Hungary: National Institute of Pharmacy and Nutrition
  • Iceland: Icelandic Medicines Agency
  • Ireland: Health Products Regulatory Authority (HPRA)
  • Italy: Italian Medicines Agency
  • Kazakhstan: National Center for Drug Expertise, Medical Devices and Medical Equipment
  • Latvia: State Agency of Medicines
  • Liechtenstein: Office of Health/Department of Pharmaceuticals
  • Lithuania: State Medicines Control Agency
  • Luxembourg: Ministry of Health
  • Malta: Medicines Authority
  • Netherlands: Healthcare Inspectorate
  • Netherlands: Medicines Evaluation Board
  • Norway - The Norwegian Medicines Agency
  • Poland: Chief Pharmaceutical Inspectorate
  • Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • Portugal: National Authority of Medicines and Health Products, IP (INFARMED)
  • Romania: National Agency for Medicines Agency
  • Russian Federation: Ministry of Public Health
  • Slovakia: State Institute for Drug Control (SIDC)
  • Slovenia: Agency for Medicinal Products and Medical Devices (ARSZMP)
  • Spain: Spanish Agency of Medicines and Medical Devices (AEMPS)
  • Sweden: Medical Products Agency (MPA)
  • Tajikistan: Ministry of Health of the Republic of Tajikistan
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA)

North and South America

• Regional/Harmonization Organizations
  • Mercado Comun del Sur (MERCOSUR)
  • Pan American Health Organization
  • Pan American Network for Drug Regulatory Harmonization (PANDRH)
• Central and South America Regulatory Authorities
  • Argentina: National Administration of Drugs, Food & Medical Technology
  • Brazil: Health Surveillance Agency (ANVISA)
  • Chile: Ministry of Health
  • Colombia: National Institute of Food and Drug Monitoring (INVIMA)
  • Costa Rica: Ministry of Health
  • Cuba: Center for State Control of Drugs, Medical Devices
  • Dominican Republic: Directorate General of Drugs and Pharmacies
  • Honduras: Directorate General of Health Regulation
  • Panama: Ministry of Health
  • Peru: Ministry of Health
  • Uruguay: Ministerio de Salud
  • Venezuela: National Institute of Hygiene
• North America Regulatory Authorities
  • Canada: Health Canada
  • Mexico: Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
  • United States: Food and Drug Administration (FDA)

Middle East

• Jordan: Jordan Food and Drug Administration
• Israel: Ministry of Health
• Saudi Arabia: Saudi Food and Drug Authority
• United Arab Emirates: Ministry of Health
• Yemen: Supreme Commission for Drugs and Medical Appliances

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