我国新药生产市场准入制度的相关问题研究

Relevant Problems of New Drug Manufacture Market Access System in China

目的:为完善我国新药生产市场准入制度提供参考。方法:从药品市场准入制度的内涵、模式和主要内容入手,运用文献研究、对比研究的方法,深入分析我国新药生产市场准入制度的现状、存在的主要问题及原因,并提出建议。结果与结论:我国新药生产市场准入制度存在法律体系不规范、准入条件繁多、审批效率低、生产许可证和批准文号捆绑、生产许可和《药品生产质量管理规范》(GMP)审核条件重复等问题,应该借鉴美国等发达国家的经验加以完善,建议采取生产企业注册登记制、实行GMP产品认证、引入上市许可人制度等。

OBJECTIVE： To improve new drug manufacture market access system in China.METHODS： This paper started the research from the meaning,mode and the main content of market access system,and made deep analysis on the current situation,main problems and the reason of the new drug manufacture market access system in China,using literature research and comparative research methods.RESULTS CONCLUSIONS： There are many problems about non-standard legal system and multiple access procedures,low approval efficiency,manufacturing license bound with registered number of approval,and duplication of production permit and GMP verification,etc.We should learn the successful experiences from US and other countries to improve it.It is suggested to take registration system for manufacturers,implement GMP product certification,and introduce MAH system.