Analysis of Drug Manufacturer on Post-marketing Drug Risk Monitoring and Management Status in China

Abstract

Abstract: Objective To evaluate the drug manufacturer's abilities on the post-marketing drug safety monitoring and risk control at the present stage in China. Methods China adverse drug reaction(ADR) database, the literatures in domestic bibliographic databases, and the risk management measures in CFDA website were analyzed. Results The pharmcovigilance organizational system of drug manufacturers in China were established almost, but the abilities of ADR reports collecting, discovering and identifying the safety signals, and the implementation of the drug safety risk management measures need to be improved. Conclusion Drug manufacturers in China should change the management philosophy, expand the thinking of work, perform the duty of drug risk management practically.

Key words: drug manufacturer, post-marketing, drug risk monitoring and management

CLC Number:

FENG Hong-yun, WU Gui-zhi, FAN Yan, DONG Duo. Analysis of Drug Manufacturer on Post-marketing Drug Risk Monitoring and Management Status in China[J]. Chinese Journal of Pharmacovigilance, 2018, 15(1): 16-19.

References

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