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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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

Received: 12 April 2024

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	Articles by authors
	XU Han
	PENG Lin
	ZHANG Siwei
	WANG Bijun
	ZHAO Rong
	YANG Zehua

Cite this article:

XU Han,PENG Lin,ZHANG Siwei等. Study on the current situation and problems of joint supervision of drug registration, research and production in Hunan Province[J]. HuNan ShiFan DaXue XueBao(YiXueBan), 2024, 21(4): 169-174.

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http://yxb.hunnu.edu.cn/EN/ OR http://yxb.hunnu.edu.cn/EN/Y2024/V21/I4/169

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