| 王丹,欧阳楠,陈颖.新法规要求下药品生产检查形势与监管策略探讨[J].中国药事,2022,36(6):611-615 |
| 新法规要求下药品生产检查形势与监管策略探讨 |
| Discussion on the Situation of Drug Production Inspection and Supervision Strategy under the Requirements of New Laws and Regulations |
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| DOI：10.16153/j.1002-7777.2022.06.002 |
| 中文关键词: 药品检查 药品监管 药品生产 良好生产规范 药事管理 |
| 英文关键词: drug inspection drug supervision drug production GMP pharmaceutical administration |
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| 中文摘要: |
| 目的： 探索在新法规要求下更科学高效地开展药品生产检查的监管策略。方法：通过研究药品生产检查发展形势，分析新法规形势下面临的问题，提出关于如何更科学高效开展药品检查的建议。结果：新法规形势下，药品检查在检查协作机制、分类检查要点、行政处罚尺度和监管人员履职方面都面临新挑战。结论：建议推进药品生产企业信用评级管理制度，并出台全国性的分类检查指导文件，明确行政处罚裁量权基准，提升监管人员能力，构建协同监管体系。 |
| 英文摘要: |
| Objective: To explore the supervision strategy of carrying out drug production inspection more scientifically and efficiently under the requirements of new laws and regulations. Methods: By studying the development situation of drug production inspection and analyzing the problems under the new laws and regulations, this paper puts forward some suggestions on how to carry out drug inspection more scientifically and effi ciently. Results: Under the situation of new laws and regulations, drug inspection faces new challenges in inspection cooperation mechanism, key points of classified inspection, scale of administrative punishment and performance of supervisors. Conclusion: It is suggested to promote the credit rating management system of drug manufacturing enterprises, issue national classified inspection guidance documents, clarify the discretion benchmark of administrative punishment, improve the ability of supervisors and build a collaborative supervision system. |
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