| № | Countries | List of regulatory authorities included in the World Health Organization (WHO) Listed Authorities and/or those with Maturity Level 4 (ML-4) status |
|---|---|---|
| 1 | Austria | Austrian Federal Office for Safety in Health Care (BASG — Bundesamt für Sicherheit im Gesundheitswesen). |
| 2 | Belgium | Federal Agency for Medicines and Health Products (FAMHP). |
| 3 | Bulgaria | Bulgarian Drug Agency (BDA). |
| 4 | Canada | Health Canada. |
| 5 | Croatia | Agency for Medicinal Products and Medical Devices of Croatia (HALMED – Agencija za lijekove i medicinske proizvode). |
| 6 | Cyprus | Pharmaceutical Services, Ministry of Health (PHS-MoH). |
| 7 | Czech Republic | State Institute for Drug Control (SUKL – Státní ústav pro kontrolu léčiv). |
| 8 | Denmark | Danish Medicines Agency (DKMA – Danish Lægemiddelstyrelsen Medicines Agency). |
| 9 | Estonia | State Agency of Medicines (SAM). |
| 10 | European Medicines Regulatory Network |
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| 11 | Finland | Finnish Medicines Agency (FIMEA). |
| 12 | France | French National Agency for Medicines and Health Products Safety (ANSM — Agence nationale de sécurité du médicament et des produits de santé). |
| 13 | Germany | Federal Institute for Drugs and Medical Devices (BfArM – Bundesinstitut für Arzneimittel und Medizinprodukte). |
| 14 | Greece | National Organization for Medicines (EOF – Εθνικός Οργανισμός Φαρμάκων). |
| 15 | Hungary | National Center for Public Health and Pharmacy (NNGYK – Nemzeti Népegészségügyi és Gyógyszerészeti Központ). |
| 16 | Iceland | Icelandic Medicines Agency (IMA). |
| 17 | Ireland | Health Products Regulatory Authority (HPRA). |
| 18 | Italy | Italian Medicines Agency (AIFA — Agenzia Italiana del Farmaco). |
| 19 | Japan | Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA). |
| 20 | Latvia | State Agency of Medicines of Latvia (ZVA — Zāļu Valsts Aģentūra). |
| 21 | Liechtenstein | Office of Health / Medicinal Products Control Agency (LLV — Liechtensteinische Landesverwaltung). |
| 22 | Lithuania | State Medicines Control Agency (VVKT — Valstybinė vaistų kontrolės tarnyba). |
| 23 | Luxembourg | Ministry of Health and Social Security of Luxembourg. |
| 24 | Malta | Malta Medicines Authority (MMA). |
| 25 | Netherlands | Medicines Evaluation Board (CBG-MEB — College ter Beoordeling van Geneesmiddelen — Medicines Evaluation Board). |
| 26 | Norway | Norwegian Medical Products Agency (NOMA). |
| 27 | Poland | Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL — Urząd Rejestracji Produktów Leczniczych). |
| 28 | Portugal | National Authority of Medicines and Health Products, I.P. (INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde). |
| 29 | Republic of Korea (South Korea) | Ministry of Food and Drug Safety (MFDS). |
| 30 | Romania | National Agency for Medicines and Medical Devices of Romania (NAMMDR). |
| 31 | Saudi Arabia | Saudi Food and Drug Authority (SFDA). |
| 32 | Singapore | Health Sciences Authority (HSA). |
| 33 | Slovakia | State Institute for Drug Control (SUKL — Státní ústav pro kontrolu léčiv). |
| 34 | Slovenia | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP — Javna agencija Republike Slovenije za zdravila in medicinske pripomočke). |
| 35 | Spain | Spanish Agency of Medicines and Medical Devices (AEMPS — Agencia Española de Medicamentos y Productos Sanitarios). |
| 36 | Sweden | Swedish Medical Products Agency (SMPA). |
| 37 | Switzerland | Swiss Federal Agency (Swissmedic). |
| 38 | United Kingdom | Medicines and Healthcare products Regulatory Agency (MHRA). |
| 39 | United States of America (USA) | US Food and Drug Administration (US FDA). |
Note:
The registration period using the recognition method is on average 1-2 months after payment of the state fee.
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