The Essential List of Pharma Regulatory Authorities in Asia

May 17, 2019 - 22:49 Updated: Feb 26, 2022 - 01:20

0 242

The Essential List of Pharma Regulatory Authorities in Asia

It can be difficult to keep track of regulators on a global scale. To make finding the relevant websites for the various regulatory authorities and ministries of health around the world a little easier, Focus will be building resources for major regions.

This regional regulator database covers countries in Asia, organized by geographic region, and lists the website(s) for each country’s ministry of health and drug regulatory authority. This list also notes the country’s membership in regional organizations that have a regulatory component.

Please note, for countries that do not list a drug regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unclear. Additionally, some of the organizations listed do not appear to have websites, or the websites do not function.

In the future, Focus will expand this resource to include the bodies responsible for medical device registration. If you notice an issue with this page or wish to submit a correction please email focus at jg@prometheastech.com.

Region/Country	Regulatory Authority	Ministry of Health	Regional Affiliations
East Asia
China	China Food and Drug Administration (CFDA)	National Health and Family Planning Commission (NHFPC)	AHWP, APEC
Hong Kong	Drug Office - Department of Health	Department of Health	AHWP, APEC
Japan	Pharmaceuticals and Medical Devices Agency (PMDA)	Ministry of Health Labor and Welfare (MHLW)	APEC
Mongolia		Ministry of Health and Sports
North Korea		Ministry of Public Health
South Korea	Ministry of Food and Drug Safety (MFDS)	Ministry of Health and Welfare	AHWP, APEC
Taiwan (ROC)	Food and Drug Administration (FDA)	Ministry of Health and Welfare	AHWP, APEC
South Asia
Afghanistan	Medicines Regulatory Authority	Ministry of Public Health
Bangladesh	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)	Ministry of Health and Family Welfare	AHWP
Maldives	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)	Ministry of National Health Services, Regulations and Coordination	AHWP
Sri Lanka	Cosmetics, Devices and Drug Regulatory Authority (CDDA)	Ministry of Health
Southeast Asia
Brunei		Ministry of Health	AHWP, APEC, ASEAN
Cambodia	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	AHWP, APEC, ASEAN
Laos	Food and Drug Department	Ministry of Health	AHWP, ASEAN
Malaysia	National Pharmaceutical Control Bureau	Ministry of Health	AHWP, APEC, ASEAN
Myanmar	Food and Drug Board of Authority	Ministry of Health	AHWP, ASEAN
Philippines	Food and Drug Administration	Department of Health	AHWP, APEC, ASEAN
Singapore	Health Sciences Authority	Ministry of Health	AHWP, APEC, ASEAN
Thailand	Food and Drug Administration	Ministry of Public Health	AHWP, APEC, ASEAN
Vietnam	Drug Administration of Vietnam	Ministry of Health	AHWP, APEC, ASEAN
Western Asia/Middle East
Armenia	Scientific Centre of Drug and Medical Technology Expertise	Ministry of Health
Azerbaijan		Ministry of Health
Bahrain	National Health Regulatory Authority (NHRA)	Ministry of Health
Cyprus	Ministry of Health - Pharmaceutical Services	Ministry of Health
Egypt	Egyptian Drug Authority	Ministry of Health and Population
Georgia	Georgia Drugs and Narcotics Agency	Ministry of Health, Labour and Social Affairs
Iran	Ministry of Health and Medical Education	Ministry of Health and Medical Education
Iraq		Ministry of Health
Israel		Ministry of Health
Jordan	Jordan Food and Drug Administration	Ministry of Health	AHWP
Kuwait	Kuwait Drug and Food Control Administration	Ministry of Health	AHWP
Lebanon	Ministry of Public Health	Ministry of Public Health
Oman	Directorate General of Pharmaceutical Affairs and Drug Control	Ministry of Health
Palestine	General Directorate of Pharmacy	Ministry of Health
Qatar	Pharmacy and Drug Control	Supreme Council of Health
Saudi Arabia	Saudi Food and Drug Authority	Ministry of Health	AHWP
Syria	Directorate of Drug Control	Ministry of Health
Turkey		Ministry of Health
United Arab Emirates		Ministry of Health	AHWP (Abu Dhabi)
Yemen	Supreme Board for Medicine and Medical Appliances	Ministry of Public Health	AHWP
Central Asia
Kazakhstan	National Center for Medicines, Medical Devices and Medical Equipment Expertise	Ministry of Healthcare and Social Development
Kyrgyzstan		Ministry of Health
Tajikistan		Ministry of Health
Turkmenistan		Ministry of Health
Uzbekistan	National Information and Analytical Center on Drugs Control	Ministry of Health
South Pacific
Australia	Therapeutic Goods Administration (TGA)	Department of Health	APEC
New Zealand	Medicines and Medical Devices Safety Authority (MEDSAFE)	Ministry of Health	APEC
Papua New Guinea	Pharmaceutical Services Standards Branch - National Department of Health	National Department of Health	APEC

Other resources:

Asian Harmonization Working Party (AHWP)

Asia-Pacific Economic Cooperation (APEC)

Association of Southeast Asian Nations (ASEAN)

Note: Websites link to the native language page for each body listed above. Many websites will have an English language page as well; however, the English language page is oftentimes less complete than the native language page.