| 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 |
| |
| 引用本文： | 胡敬峰,韩莹,周勇,肖杰.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[J].中国食品药品监管,2022(1):74-79. |
| |
| 作者姓名： | 胡敬峰 韩莹 周勇 肖杰 |
| |
| 作者单位： | 山东省食品药品审评查验中心 |
| |
| 摘 要： | 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...
|
| 关 键 词： | 药品上市许可持有人 检查要点 质量保证 文件管理 缺陷项目 |
Inspections of Drug Development Organizations as Marketing Authorization Holder in Shandong:Current Situation and Discussion |
| |
| HU Jing-feng,HAN Ying,ZHOU Yong,XIAO Jie.Inspections of Drug Development Organizations as Marketing Authorization Holder in Shandong:Current Situation and Discussion[J].China Food Drug Administration,2022(1):74-79. |
| |
| Authors: | HU Jing-feng HAN Ying ZHOU Yong XIAO Jie |
| |
| Institution: | (Center for Food and Drug Evaluation and Inspection of Shandong Province) |
| |
| Abstract: | 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. |
| |
| Keywords: | Marketing Authorization Holder MAH key inspection points quality assurance defective items |
| 本文献已被 维普 等数据库收录！ |
