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Country/region | Regulatory authority | Major responsibilities |
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China | National Medical Products Administration (NMPA) (https://www.nmpa.gov.cn) | Supervise the safety of drugs (including traditional Chinese medicines (TCMs)), regulate the registration of drugs, medical devices, and cosmetics, and undertake standards management |
State Administration of Traditional Chinese Medicine (http://www.satcm.gov.cn) | Bear the overall responsibility of the regulation and development of TCMs |
Hong Kong | Chinese Medicine Regulatory Office, Department of Health (https://www.cmro.gov.hk) | Provide administrative support and implement regulatory measures |
The Chinese Medicine Council of Hong Kong (https://www.cmchk.org.hk) | Formulate and implement regulatory measures of Chinese medicine |
Taiwan | Department of Chinese Medicine and Pharmacy, Ministry of Health and Welfare (https://dep.mohw.gov.tw) | Plan and promote the administration of TCM and its related human resource, healthcare facilities, and quality improvement |
Japan | Ministry of Health, Labour and Welfare (https://www.mhlw.go.jp/english/) | Bear the overall responsibility of the improvement and promotion of social security and public health |
Pharmaceuticals and Medical Devices Agency (https://www.pmda.go.jp/english/index.html) | Conduct scientific reviews of marketing authorization application of pharmaceuticals and monitor postmarketing safety |
Korea | Ministry of Health and Welfare (http://www.mohw.go.kr/eng/index.jsp) | Coordinate and oversee health and welfare related affairs and policies |
Ministry of Food and Drug Safety (https://www.mfds.go.kr/eng/index.do) | Regulate food, pharmaceuticals, medical devices, and cosmetics |
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