Review Article

Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use

Table 1

The official websites and major responsibilities of the drug regulatory authorities.

Country/regionRegulatory authorityMajor responsibilities

ChinaNational 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 KongChinese 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
TaiwanDepartment 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
JapanMinistry 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
KoreaMinistry 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