新一轮中国药品审评审批政策改革研究

A New Round of Research on Drug Evaluation and Approval of Policy Reforms in China

文章主要针对目前中国药品审评审批政策改革所面临的困境进行一个系统性地回顾。基于目前的政策和现实情况,我们发现改革前的审评审批系统主要存在的问题是药品质量问题、药品审评审批工作大量积压以及药物创新不足。最新的改革政策主要针对这几大问题,提升药品审评审批标准,优化程序,实施仿制药质量效果一致性评价,临床试验数据的自查核查,鼓励药物创新,核查药品生产技术,建立并完善保障措施。这些政策不仅对药品监管部门,同时也对药品研发和生产企业起到了积极作用,还大幅度降低了药品审评审批工作的积压数量。但随着改革的推进,新的问题也随之出现,如药品审评审批专业人员不足,药品生产企业无法在短时间内适应改革政策,政府各部门之间的合作机制尚未形成。总之,本研究主要探讨新旧药品审评审批系统各自的问题并提出相关意见,以促进改革的推进。

It provided an overview of the latest reforming policies affecting the dilemma faced by Chinese drug evaluations and approv-als system.Drawing on the policies and current realities,it found the main problems of the old system were low drug quality,the seri-ous backlog of drug evaluation and approval and the deficient of drug innovation.The latest reforming policies were aiming at theseproblems,improving drug evaluation and approval standards and optimizing the process,carrying out generic drugs' quality and effi-cacy consistency evaluation,self-examing and verifying of drugs' clinical experiment data,encouraging drug innovation,verifyingdrug producing techniques,setting up and completing safeguarding measures.These policies had positive roles on not only the supervi-sion departments but also the drug researchers and producers,and the backlog of the evaluation and approval cases decrease signifi-cantly.The new problems also emerged from the reform,the professional personnel of drug evaluation and approval is inadequate anddrug producing enterprises could hardly be adapted to reforming policies within a short time,what's more the joint collaboration be-tween each governmental department was not up to the mark.Overall,it found the main problems of both old and new Chinese drugevaluation and approval system,also suggested approaches towards improving reforming policies.