我国开展药品上市许可持有人制度试点工作情况及相关政策建议

发布时间：2018-02-28 15:14

本文关键词： 药品上市许可持有人制度管理试点工作　出处：《中国药房》2017年04期 　论文类型：期刊论文

【摘要】：目的:了解并完善我国开展药品上市许可持有人制度试点工作。方法:分析我国药品上市许可制度存在的问题,以及美国、欧盟的药品上市许可制度的特点,归纳我国药品上市许可持有人制度试点的法律授权与内容,并对试点工作提出相关政策建议。结果与结论:我国药品"生产许可"与"上市许可"合并统一的药品上市许可制度,存在"新药"概念陈旧、药物资源浪费严重、新药研发创新动力不足等问题;而美国、欧盟施行的是药品"生产许可"与"上市许可"相分离的药品上市许可制度,其上市新药数量较多,产能利用率较高,药品安全、质量职责、风险管理等制度相对完善。我国有必要借鉴美国、欧盟的药品"生产许可"与"上市许可"相分离的管理制度,开展药品上市许可持有人制度试点工作。为了保障试点工作的有效开展,建议进一步加强和完善与药品安全管理相关的质量授权管理、药物警戒体系建立、药害救济制度建立等。
[Abstract]:Objective: to understand and improve the pilot work of drug listing licensing system in China. Methods: to analyze the problems existing in the drug listing licensing system in China and the characteristics of the drug listing licensing system in the United States and the European Union. Summing up the legal authorization and content of the pilot system of the drug listing license holder system in China, The results and conclusions are as follows: there is an old concept of "new drug" and serious waste of drug resources in the combination of "production license" and "listing license" in China. The United States and the European Union implement a drug listing licensing system, which is separate from the "production license" and the "listing license". It has a large number of new drugs on the market, a higher utilization rate of production capacity, and drug safety. Quality responsibility, risk management and other systems are relatively perfect. It is necessary for China to draw lessons from the separate management system of "production license" and "listing license" in the United States and the European Union. To ensure the effective implementation of the pilot work, it is proposed to further strengthen and improve the quality authorization management related to drug safety management and the establishment of a drug alert system. Establishment of remedy system for drug damage.
【作者单位】：北京积水潭医院药剂科;
【分类号】：R951

【相似文献】