Faster Approval Pathways US vs EU

Regulatory Requirements for Batch Release US Vs Europe

Experimental Conditions for Forced Degradation Studies

List of Regulatory Authorities in Asia

 

List of Regulatory Authorities in Asia

Region/Country	Drug Regulatory Authority	Medical Devices Regulatory Authority	Ministry of Health	Regional Affiliations
East Asia
China	National Medical Products Administration (NMPA)	National Medical Products Administration (NMPA)	National Health Commission of the People’s Republic of China	AHWP, APEC
Hong Kong	Drug Office - Department of Health	Medical Device Division – Department of Health	Department of Health	AHWP, APEC
Japan	Pharmaceuticals and Medical Devices Agency (PMDA)	Pharmaceuticals and Medical Devices Agency (PMDA)	Ministry of Health Labor and Welfare (MHLW)	APEC
Mongolia			Ministry of Health and Sports	AHWP
North Korea			Ministry of Public Health
South Korea	Ministry of Food and Drug Safety (MFDS)	Ministry of Food and Drug Safety (MFDS)	Ministry of Health and Welfare	AHWP, APEC
Taiwan (ROC)	Food and Drug Administration (FDA)	Food and Drug Administration (FDA)	Ministry of Health and Welfare	AHWP, APEC
South Asia
Afghanistan	General Directorate of Pharmaceutical Affairs, Ministry of Public Health	General Directorate of Pharmaceutical Affairs, Ministry of Public Health	Ministry of Public Health
Bangladesh	Directorate General of Drug Administration (DGDA)	Directorate General of Drug Administration (DGDA)	Ministry of Health and Family Welfare
Bhutan	Drug Regulatory Authority		Ministry of Health
India	Central Drugs Standard Control Organization (CDSCO)	Central Drugs Standard Control Organization (CDSCO)	Ministry of Health and Family Welfare	AHWP
Maldives	Maldives Food and Drug Authority	Maldives Food and Drug Authority	Ministry of Health
Nepal	Department of Drug Administration (DDA)		Ministry of Health and Population
Pakistan	Drug Regulatory Authority of Pakistan (DRAP)	Drug Regulatory Authority of Pakistan (DRAP)	Ministry of National Health Services, Regulations and Coordination	AHWP
Sri Lanka	National Medicines Regulatory Authority (NMRA)	National Medicines Regulatory Authority (NMRA)	Ministry of Health
Southeast Asia
Brunei			Ministry of Health	AHWP, APEC, ASEAN
Cambodia	Department of Drugs and Food	Department of Drugs and Food	Ministry of Health	AHWP, ASEAN
East Timor			Ministry of Health
Indonesia	National Agency of Drug and Food Control	Ministry of Health	Ministry of Health	AHWP, APEC, ASEAN
Laos	Food and Drug Department	Food and Drug Department	Ministry of Health	AHWP, ASEAN
Malaysia	National Pharmaceutical Regulatory Agency (NPRA)	Medical Device Authority (MDA)	Ministry of Health	AHWP, APEC, ASEAN
Myanmar	Food and Drug Administration	Food and Drug Administration	Ministry of Health and Sports	AHWP, ASEAN
Philippines	Food and Drug Administration	Food and Drug Administration	Department of Health	AHWP, APEC, ASEAN
Singapore	Health Sciences Authority	Health Sciences Authority	Ministry of Health	AHWP, APEC, ASEAN
Thailand	Food and Drug Administration	Food and Drug Administration	Ministry of Public Health	AHWP, APEC, ASEAN
Vietnam	Drug Administration of Vietnam	Department of Medical Equipment and Health Works (DMEHW)	Ministry of Health	AHWP, APEC, ASEAN
Western Asia/Middle East
Armenia	Scientific Centre of Drug and Medical Technology Expertise	Ministry of Health	Ministry of Health	EAEU
Azerbaijan	Center for Analytical Examination		Ministry of Health
Bahrain	National Health Regulatory Authority (NHRA)	National Health Regulatory Authority (NHRA)	Ministry of Health	AHWP
Cyprus	Pharmaceutical Services – Ministry of Health	Department of Medical and Public Health Services – Ministry of Health	Ministry of Health
Egypt	Egyptian Drug Authority	Egyptian Drug Authority	Ministry of Health and Population
Georgia			Ministry of Health, Labour and Social Affairs
Iran	Iran Food and Drug Administration	National Medical Device Directorate	Ministry of Health and Medical Education
Iraq	State Company for Provision of Medicines and Medical Appliances (KIMADIA)	State Company for Provision of Medicines and Medical Appliances (KIMADIA)	Ministry of Health
Israel	Ministry of Health – Pharmaceutical Division	Ministry of Health – Medical Device Division	Ministry of Health
Jordan	Jordan Food and Drug Administration	Jordan Food and Drug Administration	Ministry of Health	AHWP
Kuwait	Kuwait Drug and Food Control Administration	Kuwait Drug and Food Control Administration	Ministry of Health	AHWP
Lebanon	Ministry of Public Health	Ministry of Public Health	Ministry of Public Health
Oman	Directorate General of Pharmaceutical Affairs and Drug Control	Directorate General of Pharmaceutical Affairs and Drug Control	Ministry of Health	AHWP
Palestine	General Directorate of Pharmacy	General Directorate of Pharmacy	Ministry of Health
Qatar	Pharmacy and Drug Control		Ministry of Public Health
Saudi Arabia	Saudi Food and Drug Authority	Saudi Food and Drug Authority	Ministry of Health	AHWP
Syria	Directorate of Drug Control		Ministry of Health
Turkey	Turkish Medicines and Medical Devices Agency	Turkish Medicines and Medical Devices Agency	Ministry of Health
United Arab Emirates			Ministry of Health and Prevention	AHWP
Yemen	Supreme Board for Medicine and Medical Appliances	Supreme Board for Medicine and Medical Appliances	Ministry of Public Health	AHWP
North/Central Asia
Kazakhstan	National Center for Expertise of Medicines and Medical Devices	National Center for Expertise of Medicines and Medical Devices	Ministry of Healthcare	AHWP, EAEU
Kyrgyzstan	State Department of Medicine Provision and Medical Equipment	State Department of Medicine Provision and Medical Equipment	Ministry of Health	AHWP,  EAEU
Russia	Federal Service for Surveillance in Healthcare (Roszdravnadzor)	Federal Service for Surveillance in Healthcare (Roszdravnadzor)	Ministry of Health	APEC, EAEU
Tajikistan			Ministry of Health
Turkmenistan			Ministry of Health and Medical Industry
Uzbekistan	National Information and Analytical Center on Drugs Control		Ministry of Health
Oceania
Australia	Therapeutic Goods Administration (TGA)	Therapeutic Goods Administration (TGA)	Department of Health	APEC
New Zealand	Medicines and Medical Devices Safety Authority (MEDSAFE)	Medicines and Medical Devices Safety Authority (MEDSAFE)	Ministry of Health	APEC
Papua New Guinea	Pharmaceutical Services Standards Branch - National Department of Health	Pharmaceutical Services Standards Branch - National Department of Health	National Department of Health	APEC