The Essential List of Regulatory Authorities in Asia

Posted 06 April 2015 By Michael Mezher

placeholder+image

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 news@raps.org.

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.

Share this article:

Categories: Drugs, Medical Devices, Government affairs, Regulatory strategy, News, Japan, China, Taiwan, Korea, India, Asean, Middle East, Oceania, PMDA, CDSCO, TGA, Medsafe, APEC

Tags: East Asian Regulators, Southeast Asian Regulators, Central Asian Regulators, Middle Eastern Regulators, Regulatory Tracker, APEC, ASEAN, AHWP

Regulatory Exchange: Latest Updates From the Community