药品上市许可持有人制度下药品注册研发生产主体合规信息管理

Compliance information management of drug registration and research and development entities under the drug marketing authorization holder system

药品上市许可持有人制度下药品注册研发生产主体合规信息的收集对于我国药品监管部门识别风险并有针对性地启动注册核查具有重要意义。本文在总结基于风险启动注册核查模式实施以来的工作经验基础上,结合《药品注册研发生产主体合规信息管理与审查指导原则(试行)》,梳理分析我国当前对于药品研发生产主体进行药品研制活动的合规管理要求、合规信息提交以及药品监管部门对合规信息的审查流程和关注重点,为科学利用药品监管资源以及优化研发生产主体的合规信息管理提供参考。

Under the framework of the drug marketing authorization holder system,the systematic collection of compliance information from entities involved in drug registration,research and development(R&D),and manufacture is of paramount significance for regulatory authorities to identify risks and initiate targeted inspection.Building upon the accumulated experience since the implementation of the risk-based registration inspection model,this article,in conjunction with the“Guiding Principles for the Management and Review of Compliance Information for Drug Registration,R&D,and Manufacture Entities(Pilot)”,systematically reviewed and analyzed the current regulatory requirements for the compliance management of entities engaged in drug R&D and manufacture activities.It also delved into the requirements for compliance information submission,as well as the review processes and key focus areas employed by regulatory authorities in scrutinizing such compliance information.The objective is to provide a foundation for the scientific utilization of regulatory resources in optimizing the management of compliance information for entities involved in drug R&D and manufacture activities,thereby offering valuable insights for stakeholders.