湖南省药品注册研制生产联合检查现状及问题分析

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摘要 目的: 分析2023年湖南省药品注册研制生产联合检查结果, 探讨湖南省药品注册研制生产联合监管模式下提高本省企业产品质量安全的方法。方法: 通过现场问卷调查, 对2023年度湖南省范围内进行注册的药品进行现场检查和资料收集, 分析湖南省药品研制生产的总体情况和存在的问题。结果: 本研究共对2023年湖南省14种药品进行检查, 结果显示全部到达国家核查基本条件, 无缺陷条目56个, 占33.3%（56/168）;一般缺陷108个, 占64.3%（108/168）;主要缺陷4个, 占总检查条目2.4%（4/168）;严重缺陷0个。其中, 缺陷及其原因主要涉及文件管理问题、质量控制与质量保证问题、设备问题、专职检查员等方面。结论: 2023年湖南省药品注册研制生产联合检查结果为全部通过, 但监管部门仍需加快培养核查中心省级药品质量管理规范专职检查员, 加强法律法规的宣贯以提升企业主体责任意识和规范企业药品数据管理三个方面加强对药品注册联合检查的现场核查工作。

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	徐晗
	彭琳
	张思维
	王弼君
	赵蓉
	杨泽华

关键词 ：药品注册, 研制与生产, 联合检查, 现场核查, 问题分析

Abstract：Objective To analyze the results of the joint inspection of drug registration, research and production in Hunan Province in 2023, and explore the methods to improve the quality and safety of products in local enterprises under the joint supervision mode of drug registration, research and production in Hunan Province. Methods Through on-site questionnaire surveys, on-site inspections and data collection were conducted on drugs registered within Hunan Province in 2023 to analyze the overall situation and existing problems of drug development and production in Hunan Province. Results A total of 14 drugs in Hunan Province were inspected in 2023, and the results showed that all met the basic conditions for national verification, with 56 defect free items, accounting for 33.3% (56/168); 108 general defects, accounting for 64.3% (108/168); There are 4 main defects, accounting for 2.4% (4/168) of the total inspection items; There are 0 serious defects. Among them, the defects and their causes mainly involve issues with document management, quality control and assurance, equipment problems, and dedicated inspectors. Conclusion The results of the joint supervision of drug registration, research and production in Hunan Province in 2023 are still acceptable, but the regulatory authorities still need to accelerate the training of full-time inspectors for provincial drug quality management standards in the verification center, strengthen the promotion of laws and regulations to enhance the awareness of corporate responsibility, and standardize the management of drug data in enterprises to strengthen on-site verification of drug registration joint inspections.

Key words： registration of drug research and development of drugs and production joint examination on-the-spot inspection analysis of issues

收稿日期: 2024-04-12

基金资助:湖南省自然科学基金“基于‘互联网+’中药配方颗粒生产企业追溯体系建设研究”（2022JJ80006）

通讯作者: 赵蓉, E-mail：645523272@qq.com;杨泽华, E-mail：250069548@qq.com

引用本文:

徐晗, 彭琳, 张思维, 王弼君, 赵蓉, 杨泽华. 湖南省药品注册研制生产联合检查现状及问题分析[J]. 湖南师范大学学报(医学版), 2024, 21(4): 169-174. XU Han, PENG Lin, ZHANG Siwei, WANG Bijun, ZHAO Rong, YANG Zehua. Study on the current situation and problems of joint supervision of drug registration, research and production in Hunan Province. HuNan ShiFan DaXue XueBao(YiXueBan), 2024, 21(4): 169-174.

链接本文:

http://yxb.hunnu.edu.cn/CN/ 或 http://yxb.hunnu.edu.cn/CN/Y2024/V21/I4/169

[1] 何辉, 杨兰, 高磊, 等. 新形势下药品注册核查启动工作的实践和探索[J]. 中国临床药理学杂志, 2022, 38(11): 1293-1296.
[2] 葛永彬, 董剑平, 戴鹏. 药品注册核查关注的合规风险论述[J]. 中国食品药品监管, 2023 (3): 44-49.
[3] 赵怡, 朱琳. 药品注册在新药研发中的作用探析[J]. 化工管理, 2016 (35): 110
[4] 李源, 何辉, 许丹, 等. 我国药品注册合规审查体系建设的工作实践及挑战[J]. 中国临床药理学杂志, 2023, 39(10): 1516-1520.
[5] 王平, 杨胜, 张建武. 新时代药品注册管理体系的设计与构建——2020年版《药品注册管理办法》的新理念、新内容、新要求及实施进展[J]. 中国食品药品监管, 2021, (06): 8-17.
[6] 胡小娟, 曹轶. 化学药品药学研制现场核查常见问题分析[J]. 中国新药杂志, 2023, 32(8): 783-786.
[7] 颜若曦, 曹轶, 董江萍. 药品注册核查中对数据管理要求的研究[J]. 中国新药杂志, 2022, 31(2): 160-164.
[8] 杜婧, 高胜男. 药品注册核查中对技术转移方面的探讨[J]. 中国新药杂志, 2022, 31(17): 1684-1688.
[9] 汪丽, 胡春丽, 沈文娟. 药品注册研制现场核查中的问题及对策建议[J]. 中国药业, 2018, 27(24): 100-104
[10] 王明惠, 王飞宇, 刘尧. 药品注册研制现场核查的常见问题及管理途径[J]. 健康之路, 2018, 17(05): 289-290.
[11] 田晓娟, 张雪, 佟利家, 等. 药品注册研制现场核查常见问题 (药学研究原始记录) 分析[J]. 首都医药, 2014 (18): 5.
[12] SRBA J.The Missing Voice of Non-Serious Adverse Drug Reactions from MarketingAuthorisation Holders[J]. Advances in Pharmacoepidemiology & Drug Safety, 2014, 3(2): 1050-1052.
[13] MA J, KIM J, ALMANZA, et al. Inspector Perceptions of the Food and Drug Administration's Newest Recommended Food Facility Inspection Format: Training Matters[J]. J Environ Health, 2017, 79(10): 26-31.
[14] YAN K, LI Y F, ZHOU S P, et al.Application of project management for new drug research and development in pharmaceutical enterprises[J]. 2013, 27(06): 2667-2670.
[15] 张淼, 孙超. 仿制药药学研究部分研发质量管理的方法探究[J]. 中国医药工业杂志, 2022, 53(01): 125-133.