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ā | China | Taiwan | Hong Kong | Japan | Korea |
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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 |
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