Region | Country | Drug Regulatory Authority | Registration status | Registration number |
North/Central Asia | Russia | Federal Service for Surveillance in Healthcare (Roszdravnadzor) | Authorized | |
Europe | Europe | European Medicines Agency (EMA) | Authorized | |
USA | USA | U.S. Food & Drug Administration (FDA) | Application submitted | |
Western Africa | Ghana | Food and Drug Authority (FDA) | Application submitted | |
Western Africa | Nigeria | National Agency for Food and Drug Administration and Control (NAFDAC) | Application submitted | |
Southeast Asia | Vietnam | Drug Administration of Vietnam | Application submitted | |
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East Asia | China | National Medical Products Administration (NMPA) | | |
East Asia | Hong Kong | Drug Office – Department of Health | | |
East Asia | Japan | Pharmaceuticals and Medical Devices Agency (PMDA) | | |
East Asia | Mongolia | Ministry of Health | | |
East Asia | North Korea | Ministry of Health | | |
East Asia | South Korea | Ministry of Food and Drug Safety (MFDS) | | |
East Asia | Taiwan (ROC) | Food and Drug Administration (FDA) | | |
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South Asia | Afghanistan | General Directorate of Pharmaceutical Affairs, Ministry of Public Health | | |
South Asia | Bangladesh | Directorate General of Drug Administration (DGDA) | | |
South Asia | Bhutan | Drug Regulatory Authority | | |
South Asia | India | Central Drugs Standard Control Organization (CDSCO) | | |
South Asia | Maldives | Maldives Food and Drug Authority | | |
South Asia | Nepal | Department of Drug Administration (DDA) | | |
South Asia | Pakistan | Drug Regulatory Authority of Pakistan (DRAP) | | |
South Asia | Sri Lanka | National Medicines Regulatory Authority (NMRA) | | |
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Southeast Asia | Brunei | Ministry of Health | | |
Southeast Asia | Cambodia | Department of Drugs and Food | | |
Southeast Asia | East Timor | Ministry of Health | | |
Southeast Asia | Indonesia | National Agency of Drug and Food Control | | |
Southeast Asia | Laos | Food and Drug Department | | |
Southeast Asia | Malaysia | National Pharmaceutical Regulatory Agency (NPRA) | | |
Southeast Asia | Myanmar | Food and Drug Administration | | |
Southeast Asia | Philippines | Food and Drug Administration | | |
Southeast Asia | Singapore | Health Sciences Authority | | |
Southeast Asia | Thailand | Food and Drug Administration | | |
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Western Asia/Middle East | Armenia | Scientific Centre of Drug and Medical Technology Expertise | | |
Western Asia/Middle East | Azerbaijan | Center for Analytical Examination | | |
Western Asia/Middle East | Bahrain | National Health Regulatory Authority (NHRA) | | |
Western Asia/Middle East | Cyprus | Pharmaceutical Services – Ministry of Health | | |
Western Asia/Middle East | Egypt | Egyptian Drug Authority | | |
Western Asia/Middle East | Georgia | Ministry of Health | | |
Western Asia/Middle East | Iran | Iran Food and Drug Administration | | |
Western Asia/Middle East | Iraq | State Company for Provision of Medicines and Medical Appliances (KIMADIA) | | |
Western Asia/Middle East | Israel | Ministry of Health – Pharmaceutical Division | | |
Western Asia/Middle East | Jordan | Jordan Food and Drug Administration | | |
Western Asia/Middle East | Kuwait | Kuwait Drug and Food Control Administration | | |
Western Asia/Middle East | Lebanon | Ministry of Public Health | | |
Western Asia/Middle East | Oman | Directorate General of Pharmaceutical Affairs and Drug Control | | |
Western Asia/Middle East | Palestine | General Directorate of Pharmacy | | |
Western Asia/Middle East | Qatar | Pharmacy and Drug Control | | |
Western Asia/Middle East | Saudi Arabia | Saudi Food and Drug Authority | | |
Western Asia/Middle East | Syria | Directorate of Drug Control | | |
Western Asia/Middle East | Turkey | Turkish Medicines and Medical Devices Agency | | |
Western Asia/Middle East | United Arab Emirates | Ministry of Health | | |
Western Asia/Middle East | Yemen | Supreme Board for Medicine and Medical Appliances | | |
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North/Central Asia | Kazakhstan | National Center for Expertise of Medicines and Medical Devices | | |
North/Central Asia | Kyrgyzstan | State Department of Medicine Provision and Medical Equipment | | |
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North/Central Asia | Tajikistan | Ministry of Health | | |
North/Central Asia | Turkmenistan | Ministry of Health | | |
North/Central Asia | Uzbekistan | National Information and Analytical Center on Drugs Control | | |
North/Central Asia | Oceania | Ministry of Health | | |
North/Central Asia | Australia | Therapeutic Goods Administration (TGA) | | |
North/Central Asia | New Zealand | Medicines and Medical Devices Safety Authority (MEDSAFE) | | |
North/Central Asia | Papua New Guinea | Pharmaceutical Services Standards Branch – National Department of Health | | |
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Central Africa | Burundi | Burundi Food and Medicines Regulatory Authority (ABREMA) | | |
Central Africa | Cameroon | National Supply Centre for Essential Drugs and Consumables (CENAME) | | |
Central Africa | Central African Republic | Ministry of Health | | |
Central Africa | Chad | African Medicines Regulatory Harmonisation (AMRH) – Ministry of Health | | |
Central Africa | Congo | Ministry of Health | | |
Central Africa | Democratic Republic of Congo | Autorité Congolaise de Régulation Pharmaceutique (ACOREP) – Ministry of Health | | |
Central Africa | Equatorial Guinea | Ministry of Health | | |
Central Africa | Gabon | Direction du Médicament et de la Pharmacie – Ministry of Health | | |
Central Africa | Sao Tome and Principe | Ministry of Health | | |
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Eastern Africa | Comoros | Ministry of Public Health and Population | | |
Eastern Africa | Djibouti | Ministry of Health | | |
Eastern Africa | Eritrea | National Medicines and Food Administration – Ministry of Health | | |
Eastern Africa | Ethiopia | Ethiopian Food and Drug Authority (EFDA) – Ministry of Health | | |
Eastern Africa | Kenya | Pharmacy and Poisons Board (PPB) | | |
Eastern Africa | Madagascar | L’Agence du Médicament de Madagascar | | |
Eastern Africa | Mauritius | Ministry of Health and Quality of Life | | |
Eastern Africa | Rwanda | Rwanda Food and Drugs Authority (FDA) | | |
Eastern Africa | Seychelles | Health Care Agency | | |
Eastern Africa | Somalia | National Medicine Regulatory Authority (NMRA) | | |
Eastern Africa | Sudan (North) | National Medicines and Poisons Board | | |
Eastern Africa | Tanzania | Zanzibar Food And Drug Agency (ZFDA) | | |
Eastern Africa | Tanzania | Tanzania Medicines and Medical Devices Authority (TMDA) | | |
Eastern Africa | Uganda | National Drug Authority (NDA) | | |
Eastern Africa | South Sudan | Drug and food control authority – Ministry of Health | | |
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Northern Africa | Algeria | Ministère de la Santé, de la Population et de la Réforme Hospitalière | | |
Northern Africa | Egypt | The Egyptian Drug Authority (EDA) | | |
Northern Africa | Libya | Food and Drug Control Center (FDCC) – Ministry of Health | | |
Northern Africa | Mauritania | Pharmacy and Laboratories Department – Ministry of Health | | |
Northern Africa | Morocco | La Commission Nationale Consultative des Dispositifs Médicaux – Ministry of Health | | |
Northern Africa | Tunisia | Ministry of Health | | |
Northern Africa | Sahrawi Republic | Ministry of Health | | |
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Southern Africa | Angola | Regulatory Agency for Medicines and Healthcare Technologies (ARMED) – Ministry of Health | | |
Southern Africa | Botswana | Botswana Medicines Regulatory Authority (BoMRA) | | |
Southern Africa | Eswatini (Swaziland) | Ministry of Health and Social Welfare | | |
Southern Africa | Lesotho | Ministry of Health (Medicine Regulatory Unit) | | |
Southern Africa | Malawi | Pharmacy and Medicines Regulatory Authority (PMRA) | | |
Southern Africa | Mozambique | Direccao Nacional de Farmacia (DNF) – Ministry of Health | | |
Southern Africa | Namibia | Namibia Medicines Regulatory Council | | |
Southern Africa | South Africa | South African Health Products Regulatory Authority (SAHPRA) | | |
Southern Africa | Zambia | Zambia Medicines Regulatory Authority (ZAMRA) | | |
Southern Africa | Zimbabwe | Medicines Control Authority of Zimbabwe (MCAZ) | | |
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Western Africa | Benin | Benin Pharmaceutical Regulatory Agency (ABRP) – Ministry of Health | | |
Western Africa | Burkina Faso | Agence Nationale de Règlementation Pharmaceutique (ANRP) – Ministry of Health | | |
Western Africa | Capo Verde | Ministry of Health | | |
Western Africa | Cote d’Ivoire | Autorite Ivoirienne de Regulation Pharmaceutique (AIRP) – Ministry of Health | | |
Western Africa | Gambia | Medicines Control Agency – Ministry of Health | | |
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Western Africa | Guinea | Ministry of Health (MOH) | | |
Western Africa | Guinea-Bissau | Ministry of Health | | |
Western Africa | Liberia | Liberia Medicines and Health Products Regulatory Authority (LMHRA) | | |
Western Africa | Mali | Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) | | |
Western Africa | Niger | Direction de la Pharmacie et de la Médecine Traditionnelle (DPH/MT) – Ministry of Health | | |
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Western Africa | Senegal | Direction de la Pharmacie et du Médicament (DPM) – Ministry of Health | | |
Western Africa | Sierra Leone | Pharmacy Board of Sierra Leone (PBSL) | | |
Western Africa | Togo | Direction de la pharmacie, du médicament et des laboratoires (DPML) – Ministry of Health | | |
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Asean | Brunei Darussalam | Ministry of Health | | |
Asean | Cambodia | Ministry of Health | | |
Asean | Indonesia | INDONESIAN FOOD AND DRUG AUTHORITY | | |
Asean | Lao PDR | Ministry of Health | | |
Asean | Malaysia | Ministry of Health | | |
Asean | Myanmar | Ministry of Health | | |
Asean | Philippines | Ministry of Health | | |
Asean | Singapore | Health Sciences Authority | | |
Asean | Thailand | Ministry of Public Health | | |
Asean | Vietnam | Ministry of Health | | |