PHỤ LỤC 2
DANH SÁCH CƠ QUAN QUẢN LÝ DƯỢC CÁC NƯỚC THUỘC DANH SÁCH SRA
(Cập nhật tháng 11/2019)
STT
Tên cơ quan quản lý
1 Therapeutic Goods Administration (TGA)
2 Austrian Agency for Health and Food Safety (AGES)
3 Agence Fédérale des Médicaments et des Produits de Santé
(Federal Agency for Medicines and Health Products) (AFMPS)
4 Bulgarian Drug Agency
5 Health Canada - Regulatory Operations and Regions Branch (Santé
Canada - Direction générale des opérations réglementaires et des
régions) (RORB)
6 Agency for Medicinal Products and Medical Devices of Croatia
(Agencija za lijekove i medicinske proizvode) (HALMED)
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Pharmaceutical Services (CyPHS)
Státní Ústav pro Kontrolu Léčiv (State Institute for Drug Control)
(SÚKL)
Danish Medicines Agency (DKMA)
State Agency of Medicines (SAM)
Finnish Medicines Agency (FIMEA)
Agence nationale de sécurité du médicament et des produits de
santé (French National Agency for Medicines and Health Products
Safety) (ANSM)
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)
Εθνικός Οργανισμός Φαρμάκων (National Organization for
Medicines) (EOF)
National Institute of Pharmacy and Nutrition (NIPN)
The Icelandic Medicines Agency (IMA)
Health Products Regulatory Authority (HPRA)
Agenzia Italiana del Farmaco (AIFA)
1. Ministry of Health, Labour and Welfare (MHLW)
2. Pharmaceuticals and Medical Devices Agency (PMDA)
Zāļu Valsts Aģentūra (State Agency of Medicines) (ZVA)
Tên nước
Australia
Austria
Belgium
Bulgaria
Canada
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Japan
Latvia
Tên nước
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
29
Tên cơ quan quản lý
Amt für Gesundheit (Office of Healthcare) (AG)
State Medicines Control Agency (SMCA)
Ministry of Health
Medicines Authority Malta (MAM)
Inspectie Gezondheidszorg en Jeugd (Health and Youth Care
Inspectorate) (IGJ)
Norwegian Medicines Agency (NOMA)
Chief Pharmaceutical Inspectorate (CPI)
Autoridade Nacional do Medicamento e Produtos de Saúde IP
(National Authority of Medicines and Health Products IP)
(INFARMED IP)
National Agency for Medicines and Medical Devices (NAMMD)
30
31
State Institute for Drug Control (SIDC)
Agency for Medicinal Products and Medical Devices (JAZMP)
Slovakia
Slovenia
32
Agencia Española de Medicamentos y Productos Sanitarios
(Spanish Agency for Medicines and Medical Devices) (AEMPS)
Medical Products Agency (MPA)
Swiss Agency for Therapeutic Products (Swissmedic)
Medicines and Healthcare Products Regulatory Agency (MHRA)
United States Food and Drug Administration (US FDA)
Spain
STT
21
22
23
24
25
26
27
28
33
34
35
36
Norway
Poland
Portugal
Romania
Sweden
Switzerland
United Kingdom
USA