| 王胜鹏,朱炯,张弛,王翀.欧盟药品抽查检验工作程序研究[J].中国药事,2020,34(9):1070-1079 |
| 欧盟药品抽查检验工作程序研究 |
| Study on Drug Sampling and Testing Procedures of European Union |
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| DOI：10.16153/j.1002-7777.2020.09.011 |
| 中文关键词: 欧盟集中审批药品 抽查检验工作程序 组织管理 生物类似药 仿制药 |
| 英文关键词: EU centrally authorized products (CAPs) procedures for sampling and testing organization and management biosimilars generics |
| 基金项目: |
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| 中文摘要: |
| 目的：通过研究分析欧盟集中审批药品(CAPs)抽查检验工作程序，为我国修订药品抽查检验程序提供参考。方法：采用文献研究法，通过查阅相关文献以及检索欧盟药品监督管理局及欧洲药品质量管理局官方网站查找欧盟药品抽查检验工作程序相关文件与法规，就欧盟CAPs抽查检验项目开展全面分析研究。结果：梳理了欧盟CAPs抽检项目工作程序及其流程管理特点；综述了常规抽检、仿制药抽检、生物类似药抽检、平行供应链CAPs抽检、原料药抽检的项目计划管理、抽检实施管理、抽检结果运用管理的精细化举措。结论：欧盟CAPs抽查检验的精细化管理举措，以问题导向规划5年期抽查检验项目，可行性研究确证抽查检验项目的方法，对我国药品监管具有参考价值。 |
| 英文摘要: |
| Objective: To study and analyze the key points of drug sampling and testing procedures of centrally authorized products (CAPs) in European Union in order to provide references for the revision of drug sampling and testing procedures in China. Methods: By means of literature research, relevant literature reviews, the official websites of EMA and EDQM were searched to find related documents, laws and regulations of the European Union drug sampling and testing procedures and to conduct a comprehensive study of CAPs sampling and testing program. Results: The procedures for sampling and testing of CAPs and the characteristics of the sampling and testing workflow management were combed. The refined measures of general program, generics program, biosimilars program, parallel distribution program, program plan management of sampling and testing of ad hoc active pharmaceutical ingredients, implementation of sampling and testing, and the refined measures of the application and management of sampling and testing results were illustrated. Conclusion: The refined measures for organization and management of CAPs sampling and testing, problem-oriented planning of five-year CAPs sampling and testing program, the measures of conducting feasibility studies to confirm sampling and testing program, are of reference value to pharmaceutical administration in China. |
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