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| 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 ReformJin Jianwen1(Henan Province Food and Drug Evaluation and Inspection Center, Zhengzhou 450000, China) |
| 投稿时间：2020-09-19 修订日期：2021-03-08 |
| DOI： |
| 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：据调研，省级药品监管机构改革期间存在监管力量薄弱、效率低、专业人员不足等的问题，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 put forward ideas and suggestions for drug production supervision. Methods: To investigate the reform methods, number of dispatched agencies, staffing levels and existing problems of national provincial drug regulatory agencies, summarize and analyze the research results and put forward suggestions for current drug production supervision. Results and Conclusion: According to investigation, the provincial drug regulators during the period of institutional reform are faced with problems such as weak regulatory power, low efficiency, insufficient professionals. The question of incomplete national regulatory policy remains. The corporate compliance consciousness remains to be strengthened. It is suggested that supervisory departments should speed up the improvement of working mechanism and process, gradually establish a team of professional and professional inspectors, strengthen the service and training of enterprises, improve supervisory policies, adopt the concept of risk supervision, effectively utilize the limited supervisory resources, and implement precise and efficient supervision. |
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