Danh sách cơ quan quản lý dược các nước thuộc danh sách SRA (7/2021)
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STT | Tên cơ quan quản lý Dược | Tên nước |
1 | Therapeutic Goods Administration (TGA) | Australia |
2 | Cơ quan thẩm quyền cấp CPP/GMP tại Áo: 1. Austrian Agency for Health and Food Safety (AGES) 2. BASG-Bundesamt für Sicherheit im Gesundheitswesen (Austrian Medicines and Medical Devices Agency) | Austria |
3 | Agence Fédérale des Médicaments et des Produits de Santé (Federal Agency for Medicines and Health Products) (AFMPS) | Belgium |
4 | Bulgarian Drug Agency | Bulgaria |
5 | Health Canada - Regulatory Operations and Regions Branch (Santé Canada - Direction générale des opérations réglementaires et des régions) (RORB) | Canada |
6 | Agency for Medicinal Products and Medical Devices of Croatia (Agencija za lijekove i medicinske proizvode) (HALMED) | Croatia |
7 | Pharmaceutical Services (CyPHS) | Cyprus |
8 | Státní Ústav pro Kontrolu Léčiv (State Institute for Drug Control) (SÚKL) | Czech Republic |
9 | Danish Medicines Agency (DKMA) | Denmark |
10 | State Agency of Medicines (SAM) | Estonia |
11 | Finnish Medicines Agency (FIMEA) | Finland |
12 | Agence nationale de sécurité du médicament et des produits de santé (French National Agency for Medicines and Health Products Safety) (ANSM) | France |
13 | Cơ quan thẩm quyền cấp CPP/GMP tại Đức: 1. Bundesministerium für Gesundheit (Federal Ministry of Health) (BMG) 2. Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices) (ZLG). 3. Các cơ quan có thẩm quyền cấp bang/ khu vực/ cơ quan có thẩm quyền. | Germany |
14 | Εθνικός Οργανισμός Φαρμάκων (National Organization for Medicines) (EOF) | Greece |
15 | National Institute of Pharmacy and Nutrition (NIPN) | Hungary |
16 | The Icelandic Medicines Agency (IMA) | Iceland |
17 | Health Products Regulatory Authority (HPRA) | Ireland |
18 | Agenzia Italiana del Farmaco (AIFA) - Italian Medicines Agency | Italy |
19 | 1. Ministry of Health, Labour and Welfare (MHLW) 2. Pharmaceuticals and Medical Devices Agency (PMDA) | Japan |
20 | Zāļu Valsts Aģentūra (Latvian State Agency of Medicines) (ZVA) | Latvia |
21 | Amt für Gesundheit (Office of Healthcare) (AG) | Liechtenstein |
22 | State Medicines Control Agency (SMCA) | Lithuania |
23 | Ministry of Health | Luxembourg |
24 | Medicines Authority Malta (MAM) | Malta |
25 | Inspectie Gezondheidszorg en Jeugd (Health and Youth Care Inspectorate) (IGJ) | Netherlands |
26 | Norwegian Medicines Agency (NOMA) | Norway |
27 | Chief Pharmaceutical Inspectorate (CPI) | Poland |
28 | Autoridade Nacional do Medicamento e Produtos de Saúde IP (National Authority of Medicines and Health Products IP) (INFARMED IP) | Portugal |
29 | National Agency for Medicines and Medical Devices (NAMMD) | Romania |
30 | State Institute for Drug Control (SIDC) | Slovakia |
31 | Agency for Medicinal Products and Medical Devices (JAZMP) | Slovenia |
32 | Cơ quan thẩm quyền cấp CPP/GMP tại Tây Ban Nha: 1. Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices) (AEMPS). 2. Các cơ quan có thẩm quyền cấp bang/ khu vực/ cơ quan có thẩm quyền. | Spain |
33 | Medical Products Agency (MPA) | Sweden |
34 | Swiss Agency for Therapeutic Products (Swissmedic) | Switzerland |
35 | Medicines and Healthcare Products Regulatory Agency (MHRA) | United Kingdom |
36 | United States Food and Drug Administration (US FDA) | USA |
