山东省研制机构药品上市许可持有人检查现状及问题探讨

Inspections of Drug Development Organizations as Marketing Authorization Holder in Shandong:Current Situation and Discussion

目的:了解药品上市许可持有人质量管理现状,把握药品上市许可持有人检查要点和常见问题,促进药品上市许可持有人制度有效实施。方法:归纳法律法规对药品上市许可持有人的要求,统计分析2020~2021年山东省对研制机构药品上市许可持有人检查发现的缺陷项目,对常见问题进行讨论分析。结果与结论:现阶段研制机构药品上市许可持有人检查缺陷集中在质量保证和文件管理等方面。建议药品上市许可持有人建立涵盖药品全生命周期的质量保证体系和文件管理体系;建议监管机构根据风险等级制定检查频次,统一检查标准,明确检查重点,推动药品上市许可持有人制度顺利实施。

Objective:To understand the quality management situation of Marketing Authorization Holders(MAH),key inspection points and common problems,and facilitate implementation of the MAH system.Methods:This paper summarized the requirements of laws and regulations on MAH,made statistical analysis of frequently observed deficiencies with drug development organizations that serve as MAH in 2020 and 2021 in Shandong province,and analyzed the common problems.Results and Conclusion:Currently,inspection defects with MAHs that are drug development organizations focus in the areas of quality assurance and document management.It is recommended that MAHs establish a quality assurance system and a document management system covering the total product life cycle;and that regulatory agencies adjust inspection frequency according to the risk level,unify inspection standards,clarify inspection priorities,and promote implementation of the MAH system.