| 金建闻.机构改革背景下药品生产监管思路探索[J].中国药事,2021,35(3):250-256 |
| 机构改革背景下药品生产监管思路探索 |
| Exploration of Drug Production Supervision under the Background of Institutional Reform |
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| DOI：10.16153/j.1002-7777.2021.03.002 |
| 中文关键词: 机构改革 药品生产 监管 问题 思路 建议 |
| 英文关键词: institutional reform drug production supervision problems ideas suggestions |
| 基金项目: |
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| 中文摘要: |
| 目的：探索机构改革背景下药品生产监管中存在的共性问题并进行分析，为药品生产监管提出思路和建议。方法：对全国省级药品监管机构改革方式、派出机构数量、编制人数及存在的问题进行调研，总结分析调研结果并对当前药品生产监管提出建议。结果与结论：调研结果显示，省级药品监管机构改革期间存在监管力量薄弱、效率低、专业人员不足等问题，国家监管政策不完善问题依然存在，企业的合规意识仍有待加强。建议监管部门加快完善工作机制与流程，逐步建立职业化专业化检查员队伍，加强对企业的服务与培训，完善监管政策，采取风险监管理念，有效利用有限的监管资源，实施精准监管、高效监管。 |
| 英文摘要: |
| Objective: To explore and analyze the common problems existing in drug production supervision under the background of institutional reform and to put forward ideas and suggestions for drug production supervision. Methods: The way of reform, the number of dispatching agencies, the number of registered staff and the existing problems of some provincial drug regulatory agencies throughout the country were investigated, the research results were summarized and analyzed, and suggestions for current drug production supervision were put forward. Results and Conclusion: According to investigation, the problems of weak regulatory power, low efficiency, insufficient professionals and so on exist in the provincial drug agencies during the period of institutional reform. The problem of imperfect national regulatory policy still exists. The compliance awareness of enterprises needs to be strengthened. It is suggested that regulatory authorities accelerate the improvement of working mechanism and process, gradually establish a professional and specialized team of inspectors, strengthen the services and training of enterprises, improve regulatory policies, adopt the concept of risk-based supervision, effectively utilize the limited regulatory resources, and implement precise and efficient supervision. |
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