从新版《药品注册管理办法》看我国药品优先审评审批制度的变化

目的 阐述我国优先审评制度的发展过程及新版《药品注册管理办法》关于加快审评审批制度,并与既往优先审评审批制度以及美国加速审评审批制度进行比较和分析,旨在为业界提供参考。方法 采用对比分析法,比较了新版《药品注册管理办法》实施前后药品加快审评审批制度的变化,并与美国加快审评审批相关制度进行对比。结果 新版《药品注册管理办法》中关于加快审评审批制度设计更加突出以临床价值为导向的鼓励创新,细化了程序和要求,使得加快审评审批制度更具可操作性。在与美国加快审评审批制度进行对比发现,新加快审评审批制度在与国际接轨的同时,还结合了我国的临床实践、患者人群范围、发病特点以及药品监管需要等,更加符合我国国情。结论 新版《药品注册管理办法》的修订将使我国药品注册加快审评审批制度更趋完善。

Insights into Changes to the Priority Review System from the Perspective of the New Provisions for Drug Registration in China

OBJECTIVE To provide reference for those engaged in regulatory affairs by describing briefly the development process of China's priority review system and the accelerated drug review and approval system as set forth in the Provisions for Drug Registration (new edition), and making a comparison with the previous priority review system and the related systems in the United State. METHODS The changes in the accelerated drug review and approval system following vs. prior to the implementation of the Provisions for Drug Registration (new edition) were compared using comparative analysis method, and a comparison was made with the related systems in regard to accelerated review and approval in the United States. RUSULTS The accelerated drug review and approval system in the Provisions for Drug Registration (new edition) is more focused on encouraging innovations based on clinical values, and provides more details procedures and requirements, making the system more operable. In comparison with the related systems in the United States, it has been found that the new accelerated drug review and approval system not only integrates itself into the international standards, but also takes into account China's clinical practice, scope of patient populations, characteristics of disease onset and regulatory needs, etc. making it more consistent with the domestic conditions. CONCLUSION The amendments to the Provisions for Drug Registration will contribute to a more completed accelerated drug review and approval system.