| 摘要: |
| 目的 通过分析目前药包材质量控制现状，提出新形势下药包材科学监管的对策建议。方法 总结梳理我国药包材的发展情况和近40年药包材监管法规发展历程，调研长三角地区84家药包材生产和使用企业的质量控制现状并进行分析，对比研究国际相关监管模式和理念。结果 药包材关联审评政策在我国尚处于初期阶段，目前药包材监管存在的问题主要在政策法规标准完善以及理解执行方面、企业检验研究能力方面以及与国外相比还存在一些不足。结论 在新的法规要求和发展形势下，针对药包材的特点，建议总结经验做法，借鉴国外先进理念，在制度完善、平台优化、标准建设、日常监管以及加大政策宣贯和培训指导方面有更多监管策略的探索，提升药包材质量控制水平，保障药品安全。 |
| 关键词: 药包材 质量控制 监管对策 现状调研 |
| DOI： |
| 分类号: |
| 基金项目:2023年上海市药品监督管理局专项课题(ZX-2023-04) |
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| Investigation and Analysis of the Current Situation of Pharmaceutical Packaging Material and Regulatory Countermeasures under the New Situation |
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ZHOU Yaju
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Shanghai Food and Drug Packaging Material Control Center
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| Abstract: |
| OBJECTIVE To put forward suggestions on scientific supervision of pharmaceutical packaging materials by analyzing the current situation of quality control of pharmaceutical packaging materials. The quality and safety of pharmaceutical packaging materials have a very important impact on ensuring the safety and effectiveness of drugs. Under the new regulatory requirements and development situation, the quality control of pharmaceutical packaging materials has also undergone corresponding changes. METHODS Summarized and sorted out the development of pharmaceutical packaging materials in China and the development process of pharmaceutical packaging material regulatory regulations in the past 40 years, investigated the quality control status of 84 pharmaceutical packaging material production and use enterprises in the Yangtze River Delta region and analyzes them, compared and studied relevant international regulatory models and concepts. RESTULTS The new regulatory of drug packaging material is still in its early stages in China, and there are still some unresolved issues, mainly in terms of the improving, understanding and implementing regulatory regulations and standards, enterprise inspection and research capabilities, and there are still some shortcomings compared to foreign countries. CONCLUTION Under the new regulatory requirements and development situation, based on the characteristics of pharmaceutical packaging materials, it is recommended to summarize experience and practices, learn from advanced foreign concepts, and explore more regulatory strategies in institutional improvement, platform optimization, standard construction, daily supervision, and increased policy promotion and training guidance to improve the quality control level of pharmaceutical packaging materials and ensure drug safety. |
| Key words: pharmaceutical packing material quality control regulatory countermeasures current situation research |
