我国药品安全黑名单制度的相关问题探讨

Discussion on the Issues of Drug Safety Debarment Processes of China

目的:分析我国药品安全黑名单制度存在的问题并提出完善策略。方法:借鉴FDA黑名单制度的经验,结合我国药品管理现状及相关法律法规进行分析。结果:我国药品安全黑名单制度存在覆盖范围小、惩戒力度不够、操作性不强等问题。结论:建议从扩大覆盖范围、与药品安全信用体系建设有机结合、完善相关条款等方面完善黑名单制度。

Objective：To analyze the issues of drug safety debarment processes of China, and to provide perfect strategies. Meth- ods ： Draw lessons from the experience of FDA＇s debarment processes, and integrate the present situation of drug supervision and rel evant laws and regulations in china. Results： There are some problems in the drug safety debarment processes of China： small blacklist coverage, inadequate punishment, lack of operability, etc. Conclusion ： To perfect the debarment processes with the methods of expanding coverage, integrating the drug safety credit system construction, perfecting relevant clauses, etc.