Countries and their Pharma regulatory authority
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This document lists various countries and their respective regulatory authorities for drugs and medical devices. It includes over 50 countries from regions like Europe, Asia, Africa, North America, South America, and Oceania. For each country, it provides the name of the regulatory agency or government ministry responsible for oversight of pharmaceuticals and medical products in that jurisdiction. The regulatory authorities range from specialized drug agencies to broader health ministries.
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To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
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Countries and their Pharma regulatory authority
- 1. Country Regulatory Authority Australia Therapeutic Goods Administration (TGA) Argentina National administration of Drugs, Food & Medical Technology (ANMAT) Armenia Drug & medical Technology Centre, Ministry of Health Austria Federal ministry for Health Brazil National Agency for Sanitary Vigilancia (ANVISA) Belgium Federal public services( FPS) Health Bolivia Ministry of Health and Sports Bulgaria Bulgarian Drug Agency (BDA) Canada Health Canada China State Food and Drug Administration (SFDA) Colombia National Institute of Food and Drug monitoring( INVIMA) Croatia Ministry of Health and Social Welfare Denmark Danish Medicines Agency Ecuador Ministry of Public Health Egypt Ministry of Health & population Estonia State Agency of Medicines Europe European Medicines Agency (EMEA) Fiji Ministry of Health Finland Finnish Medicines Agency France French Agency for Sanitary Safety of Health Products, ministry of Health
- 2. Germany Federal Institute for Drugs and Medical Devices Georgia Ministry of Labor, Health and Social Affairs of Georgia Greece National Organization for Medicines (EOF) Guam Department of Public Health and Social Services Hong Kong Department of Health: Pharmaceutical Services Hungary National Institute for Pharmacy Iceland Icelandic Medicines Agency India Central Drug Standard Control Organization (CDSCO) Ireland Irish Medicines Board Italy Italian Pharmaceutical Agency Jamaica Ministry of Health Japan Ministry of Health, Labour & Welfare(MHLW) Jordan Ministry of Health Kenya Ministry of Health Latvia State agency of medicines Lithuania State Medicines Control Agency Maldives Ministry of Health and Family Malaysia National Pharmaceutical Control Bureau, Ministry of Health Mauritius Ministry of Health and Quality of Life Namibia Ministry of Health and Social Services Nepal Ministry of Health and Population New Medicines and Medical Devices Safety Authority (MEDSAFE)
- 3. Zealand Nigeria National Agency for Food and Drug Administration and Control (NAFDAC) Norway Norwegian Medicines agency Panama Ministry of Health Paraguay Department of Health: Pharmaceutical Services Poland Ministry of Health & Social Welfare Portugal The National Institute of Pharmacy and Medicines Romania National Medicines Agency (ANM) Russia Ministry of Health and Social Development Senegal Ministry of Health & Prevention Serbia Medicines and Medical devices Agency (ALIMS) Singapore Center for Pharmaceutical Administration Health Sciences Authority South Korea Food and Drug Administration South Africa Medicines Control Council (MCC) Spain Medicines and Health Product Agency (AEMPS) Switzerland Swiss Agency for Therapeutic Products (SWISSMEDIC) Taiwan Department of Health Tanzania Ministry of Health and Social Welfare Thailand Ministry of Public Health UK Medicines and Healthcare Products Regulatory Agency (MHRA) USA Food and Drug Administration (FDA)
- 4. Table 1 : List of countries and their Regulatory Authority (ICH-CTD) Uruguay Ministry of Public Health Venezuela Ministry of Public Health Vietnam Ministry of Health Yemen Ministry of Public Health and Population Zimbabwe Medicine Control Authority of Zimbabwe (MCAZ)