现阶段药品注册检验启动工作要求及面临的挑战

Requirements and Challenges of Starting the Drug Registration Testing at the Current Stage

目的:通过对现阶段注册检验启动工作要求、衔接等方面的显著变化的阐述,为药品审评审批改革新形式下注册检验启动工作的继续推进与完善提供参考。方法:从药品注册检验启动的政策变化历程、具体工作要求中注册检验启动的情形和流程以及与药品检验机构的衔接等方面详细介绍了注册检验启动工作的实施情况。结果与结论:结合实际存在的问题进行了分析和讨论,应加强落实申请人主体责任、优化药品注册检验启动情形和流程、完善药品技术审评与注册检验衔接程序,从而进一步促进落实注册检验启动工作的相关要求,提高工作质量和效率。

Objective: To describe the signifi cant changes in the requirements and connection of drug registration testing initiation work at the current stage, so as to provide reference for the continuous promotion and improvement of the registration testing initiation work under the new form of drug review and approval reform.Methods: This article introduces the implementation of the initiation of drug registration testing work in detail from the policy change process, the specific work requirements, the situation and process of drug registration testing initiation, and the connection with the drug testing agency. Results and Conclusion: In order to further promote the implementation of the relevant requirements for the registration testing initiation work and improve the work quality and e ffi ciency, the actual existing problems were analyzed and discussed. The implementation of the main responsibilities of the applicant should be strengthened, the starting situation and process of drug registration testing should be optimized, and the connection procedure between drug technical review and registration testing work should be improved.