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中国医药导刊 ›› 2023, Vol. 25 ›› Issue (7): 714-722.

• 监管科学 • 上一篇    下一篇

完善新时代药品执法体系机制思考

 田蕊1, 郭亮1, 徐匡根1,2*   

  1. 1.南昌大学公共卫生学院,江西省预防医学重点实验室, 江西 南昌 330006;
    2.江西省药品监督管理局, 江西 南昌 330029
  • 收稿日期:2022-05-23 修回日期:2023-07-15 出版日期:2023-07-28 发布日期:2023-07-28
  • 基金资助:
    江西省药品监督管理局科研项目(项目编号:2019GL06;项目名称:大市场监管体系江西省药品监管机制研究)

Thinking on Improving the Mechanism of Drug Law Enforcement System in the New Era

  1. 1.School of Public Health,Nanchang University, Jiangxi Province Key Laboratory of Preventive Medicine,Jiangxi Nanchang 330006,China;  2.Jiangxi Drug Administration, Jiangxi Nanchang 330029, China
  • Received:2022-05-23 Revised:2023-07-15 Online:2023-07-28 Published:2023-07-28

摘要: 目的:全面梳理全国药品执法体系改革现状和江西省基层药品执法体系改革现状,以江西省为例探讨市场监管执法体系与药品监管执法信息沟通变革,提出完善新时代药品执法体系的相关意见和建议,构建新时代药品执法体系机制的对策思路。方法:基于国家药品监督管理局官网公布的部分省(自治区、直辖市)药品综合执法改革机构设置和管理体制有关数据,并结合基层药品监管部门机构改革中面临的信息沟通、执法人员情况及人力资源配置等展开统计分析。结果:省级药品监管稽查办案机制分为单独稽查办案机制、派出机构办案机制和业务处室办案机制;药品监管执法体系模式主要为稽查处室或业务处室+派出机构。以江西省为例,机构改革后江西省药品监管机构只设到省一级,市县级药品流通监管工作由市场监管部门统一承担;进一步分析基层药品监管部门基层执法力量,在100个县(区)中,基层药品执法人员1217名,每万人口配备执法人员0.27名,每万人口*面积配备执法人员0.02名;年龄以46~55岁最多,占32.05%;学历以本科为主,占总人数的44.12%;医药类专业占22.37%。结论:应进一步加强顶层设计,完善检查执法体系,强化药品稽查办案机制,加强执法队伍建设,加快建立健全的科学、高效、权威的药品执法体系。

关键词: font-size:medium, ">药品稽查执法;药品监管;执法能力

Abstract: Objective: To comprehensively review the current situation of the reform of national drug law enforcement system and the grassroots drug law enforcement system in Jiangxi province. Take Jiangxi province as an example to discuss the reform of market supervision and law enforcement system and drug regulatory law enforcement information communication, put forward opinions and suggestions on improving drug law enforcement system in the new era, and the countermeasures and ideas for constructing drug law enforcement system in the new era. Methods:Based on the data about the institution setting and management system of comprehensive drug law enforcement reform in some provinces (autonomous regions and municipalities directly under the central government) published on the official website of the National Medical Products Administration, and combined with the situation of information communication, law enforcement personnel and human resource allocation of grassroots drug regulatory departments in the institutional reform, the statistical analysis was carried out. Results:The case-handling mechanism of provincial drug supervision and inspection was divided into individual case-handling mechanism, dispatched agency case-handling mechanism and business office case-handling mechanism. Drug regulatory law enforcement system model mainly consists of inspection office / business office and dispatched agency. Taking Jiangxi province as an example, after the reform, the drug regulatory agency was only set up at the provincial level, and the drug circulation supervision at the city and county level was uniformly undertaken by the market supervision department. Further analysis of the grassroots law enforcement forces of drug regulatory departments showed that in 100 counties (districts), there were 1217 grassroots drug law enforcement personnel, 0.27 per 10 000 population and 0.02 per 10 000 population * area. In these personnel, 46-55 years old accounted for 32.05%, bachelor degree mainly, accounting for 44.12%, and medical majors accounted for 22.37%. Conclusion:It is necessary to further strengthen the top-level design,improve the inspection and law enforcement system,strengthen drug inspection and case-handling mechanism,strengthen the construction of law enforcement team,and speed up the establishment and improvement of the scientific,efficient and authoritative drug law enforcement system.

Key words: font-size:medium, ">Investigation and law enforcement; Drug supervision; Law enforcement ability

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