| 赖秋洁,茅宁莹.我国省级药品检查机构的改革困境分析[J].中国药事,2021,35(5):487-496 |
| 我国省级药品检查机构的改革困境分析 |
| On the Reform Predicament of the Provincial Drug Inspection Institutions in China |
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| DOI：10.16153/j.1002-7777.2021.05.001 |
| 中文关键词: 药品检查 检查机构 改革 困境 |
| 英文关键词: drug inspection inspection institutions reform predicament |
| 基金项目:国家社会科学基金重大项目“我国创新药物政策环境研究”(编号15ZDB167)；中国药品监督管理研究会项目“职业化专业化药品检查员队伍建设研究” |
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| 摘要点击次数: 742 |
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| 中文摘要: |
| 目的：为完善省级药品检查机构的制度体系提供建议。方法：基于药物政策分析、文献研究和问卷调研，回顾省级药品检查机构的发展历程及改革现状，分析省级药品检查机构的改革困境，并提出对策和建议。结果与结论：省级药品检查机构设置的主流模式为“省级检查机构+多个检查分支机构”，由于许多工作还在探索中，目前仍存在药品检查配套制度有待探索，检查员队伍规模及专业能力难以满足监管需求，药品检查岗位吸引力不足，信息共享机制尚需完善等问题。建议通过健全药品检查配套制度、科学测算人员编制需求、建立药品检查信息管理平台以及明确检查工作衔接流程等多个方面加以完善。 |
| 英文摘要: |
| Objective: To provide references for improving the institutional system of provincial drug inspection agencies. Methods: Based on the drug policy analysis, literature research and questionnaire survey, the development process and reform status of provincial drug inspection institutions were reviewed, the reform difficulties of provincial drug inspection institutions were analyzed, and countermeasures and suggestions were put forward. Results and Conclusion: The main structure of the pharmaceutical inspection institutions at the provincial level is "provincial inspection agencies + multiple inspection branches". As a lot of work is still being explored, there remain many problems to be solved. For example, a supporting system for drug inspection needs to be set up, the scale and professional ablitities of the inspector team can hardly meet regulatory requirements, the drug inspection positions are not attractive enough, and the information sharing mechanism remains to be improved. Therefore, it is suggested to improve the drug inspection supporting system, scientifically calculate the staffing requirements, establish the information management platform for drug inspections, clarify the connection process of the inspection work and so on. |
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