Objective: To study the risk management of drug damage events under the system of marketing authorization holder in Germany and Japan and to provide suggestions and references for establishing and improving the risk management of drug damage events in China. Methods: The application of legal liability, the compensation mechanism of clinical trial damages and the relief mechanism system of adverse drug reactions after marketing concerned with drug damage events under the system of marketing authorization holder in Germany and Japan were compared by means of literature analysis. Results and Conclusion: The drug damage events in Germany applied to the medicinal product liability and tort liability. The risk management measures for clinical trials and post-marketing drug damage were insurance measures. The drug damage events in Japan applied to tort liability and product liability and the risk manage measures were insurance plus relief measures. The practices in Germany might be more suitable for China in balancing interests between victims and enterprises.
Zou Yixuan, Chen Yun, Liu Pengcheng, Zhou Bin, Shao Rong
. Study on Risk Management of Drug Damage Events under the System of Marketing Authorization Holder in Germany and Japan[J]. Chinese Pharmaceutical Affairs, 2018
, 32(3)
: 362
-366
.
DOI: 10.16153/j.1002-7777.2018.03.012
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