文章摘要
陈家润,江映珠,孟兰贞,王晓英,吴雪龙,张一凡.广东省医疗机构中药制剂注册申报存在问题及对策[J].中国药事,2019,33(10):1097-1101
广东省医疗机构中药制剂注册申报存在问题及对策
Problems in the Registration of Traditional Chinese Medicine Preparations of Medical Institutions in Guangdong Province and the Countermeasures
投稿时间:2019-05-16  
DOI:10.16153/j.1002-7777.2019.10.003
中文关键词: 医疗机构制剂  注册  问题  对策
英文关键词: preparations of medical institutions  registration  problems  countermeasures
基金项目:
作者单位
陈家润 广东省药品监督管理局审评认证中心, 广州 510080 
江映珠 广东省药品监督管理局审评认证中心, 广州 510080 
孟兰贞 广东省药品监督管理局审评认证中心, 广州 510080 
王晓英 广东省药品监督管理局审评认证中心, 广州 510080 
吴雪龙 广东省药品监督管理局审评认证中心, 广州 510080 
张一凡 广东省药品监督管理局审评认证中心, 广州 510080 
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中文摘要:
      目的:分析广东省医疗机构中药制剂注册申报存在的问题,为促进医疗机构中药制剂的研发与发展提供参考。方法:通过对2016-2018年60份广东省医疗机构中药制剂注册申报资料进行梳理、归纳,从技术角度阐述医疗机构中药制剂注册申报资料存在的不足。结果与结论:经过技术审评,符合《医疗机构制剂注册管理办法》(试行)有关规定的申报资料24份,通过率为40%。对未通过技术审评的36份注册申报资料的各项目进行系统分析发现,自《医疗机构制剂注册管理办法》实施以来,医疗机构中药制剂研发水平虽有较大程度的提高,但在协定处方使用历史、配制工艺研究、药用辅料使用、直接接触制剂的包装材料和容器选择、申报资料完整性等方面仍存在诸多问题,有较大的提升空间。建议医疗机构引入制剂质量源于设计(quality-by-design,QbD)的研发理念,加大对医疗机构制剂的重视程度;医疗机构制剂注册配套的法规要及时出台,以促进其逐步完善。
英文摘要:
      Objective: To analyze the problems in the registration of traditional Chinese medicine preparations of medical institutions in Guangdong Province and to provide references for promoting the research and development of traditional Chinese medicine preparations of medical institutions.Methods: 60 registration documents of traditional Chinese medicine preparations of medical institutions in Guangdong from 2016 to 2018 were analyzed and summarized, and the shortcomings of the registration data of traditional Chinese medicine preparations were elaborated from the technical point of view.Results and Conclusion: After technical review, 24 registration documents met the relevant provisions of the "Administrative Measures for the Registration of Pharmaceutical Preparations of Medical Institutions"(Trial), with a pass rate of 40%. Each item in the 36 registration documents, which were not approved by technical review was systematically analyzed. The findings showed that the level of research and development of traditional Chinese medicine preparations of medical institutions has been greatly improved since the implementation of "Administrative Measures for the Registration of Pharmaceutical Preparations of Medical Institutions", but there is still a great deal of room for improvement in the history of prescription use, the study of preparation process, the use of pharmaceutical excipients, the selection of drug packing material and containers and the completion of registration data. It is suggested that the development concept of the quality-by-design (QbD) should be introduced by the medical institutions, the emphasis on medicine preparations should be increased, and the regulations for the registration of medicine preparations of medical institutions should be promulgated in time.
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