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The Essential List of Regulatory Authorities in Asia

Posted 07 January 2020 | By Michael Mezher 

The Essential List of Regulatory Authorities in Asia

To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.
 
For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unclear. Additionally, some of the agencies listed do not appear to have websites, or the websites are not functioning as of this publication.
 
If you notice an issue with this page or wish to submit a correction please email Focus at news@raps.org.
 

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
 
Other resources:          
Asian Harmonization Working Party (AHWP)
Asia-Pacific Economic Cooperation (APEC)
Association of Southeast Asian Nations (ASEAN)
Eurasian Economic Union (EAEU)

 
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 oftentimes does not contain complete information.


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