Drug Safety Evaluation in China
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Purpose of Review
This review aimed to introduce the regulations management and current situations of drug safety evaluation in China.
The nationwide implementation of good laboratory practice and good clinical practice guarantees the quality of pre-marketing drug safety evaluation. In recent years, post-marketing drug safety monitoring is changing from passive mode to the combination of active and passive monitoring. A national adverse drug reaction monitoring sentinel alliance has been created to actively identify, report, and evaluate adverse reactions, with more than 1.4 million cases reported in 2017. But the quality of the reports is not optimal, with few reports from drug manufacturers, low rate of severe reports, and trend of lag reporting.
Drug safety evaluation in China is transitioning from passive monitoring to a combination mode. Drug pharmacovigilance is a powerful tool for active monitoring, but participation by drug manufacturers would be essential to an effective drug safety evaluation system.
KeywordsDrug safety evaluation China Good laboratory practice Good clinical practice Adverse drug reaction Traditional Chinese medicine
We thank DONG Jiangping (chief pharmacist, Center for Food and Drug Inspection of National Medical Products Administration), DONG Duo (chief pharmacist, National Center for Adverse Drug Reaction Monitoring, China), and HUO Yan (research fellow, National Institutes for Food and Drug Control) for their great help in revising this manuscript.
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
Human and Animal Rights
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: •• Of major importance
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