PHỤ LỤC 1

DANH SÁCH CƠ QUAN QUẢN LÝ THAM CHIẾU

STT Tên cơ quan quản lý dược Tên nước

1 Therapeutic Goods Administration (TGA) Australia
2 Austrian Agency for Health and Food Safety (AGES) Austria

3 Agence Fédérale des Médicaments et des Produits de Belgium

Santé (Federal Agency for Medicines and Health
Products) (AFMPS)
4 Health Canada - Regulatory Operations and Regions Canada
Branch (Santé Canada - Direction générale des
5 European Medicines Agency (EMA) Châu Âu (EMA)
6 Danish Medicines Agency (DKMA) Denmark
7 Agence nationale de sécurité du médicament et des France
8 produits
1. de santé (French
Bundesministerium für National Agency
Gesundheit for
(Federal Germany
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)
9 Health Products Regulatory Authority (HPRA) Ireland

10 1. Ministry of Health, Labour and Welfare (MHLW) Japan

2. Pharmaceuticals and Medical Devices Agency
(PMDA)
11 Inspectie Gezondheidszorg en Jeugd (Health and Netherlands
Youth Care Inspectorate) (IGJ)
12 Medical Products Agency (MPA) Sweden
13 Swiss Agency for Therapeutic Products (Swissmedic) Switzerland
14 Medicines and Healthcare Products Regulatory United Kingdom
Agency (MHRA)
15 United States Food and Drug Administration (US United States of
FDA) America