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 6

Comparison of adverse drug reactions (ADRs) monitoring system for TM/CM products.

	China	Taiwan	Hong Kong	Japan	Korea
Major ADRs monitoring agency	(1) National center: National Center for ADRs Monitoring, China Center for Drug Reevaluation; (2) Regional centers: each province has its regional center	The Department of Chinese Medicine and Pharmacy, the Ministry of Health and Welfare	Drug Office, the Department of Health	The Ministry of Health, Labour and Welfare; the Pharmaceuticals and Medical Devices Agency	(1) National center: Korea Institute of Drug Safety & Risk Management; (2) Regional centers: the Regional Pharmacovigilance Center
Technical system for ADRs reporting	Direct Reporting System of ADRs	Taiwan ADRs Reporting System for TCM	ADRs Online Reporting	ADRs and Infection Reporting Systems	Decentralized Pharmacovigilance System, National Pharmacovigilance Network
ADRs reporter	Pharmaceutical companies, hospitals, pharmacies, drug distributors, and marketing authorization holders	Medical care institutions, pharmacies, and license holders of all approved medical products	Healthcare professionals and pharmaceutical industry	Manufacturers and healthcare professionals	Pharmacies and hospitals, pharmaceutical companies
A member of the WHO Programme	Y	N	N	Y	Y
Included in spontaneous ADRs reporting system	Y	Y	Y	Y	Y
the ADRs monitoring for TM/CM product	Y	Y	Y	Y	Y
Disclosed ADRs reports on TM/CM product	Y	Y	Y	Y	N

Y: yes; N: no.