中圖分类号 R951文献标志码 A文章编号 1001-0408（2019）22-3030-05
DOI 10.6039/j.issn.1001-0408.2019.22.02
摘 要 目的：为保障临床用药安全和促进医疗机构特色化学药制剂发展提供参考。方法：从新制剂注册申报、补充申请申报、再注册申报这3个方面对广东省医疗机构化学药制剂注册申报技术审评过程中发现的问题进行归纳，分析引发上述问题的原因并给出相关建议。结果与结论：医疗机构化学药新制剂注册申报存在立题依据不充分、配制工艺研究缺少关键工艺参数、稳定性考察试验条件不符合药典要求等问题;补充申请申报存在处方组成不合理、内包材与药物发生相互作用、贮藏条件设定不合理等问题;再注册申报存在市场上已有药品供应、申报单位不具备生产条件、原辅料无法购买、注意项不完整等问题。造成这些问题的主要原因是化学药制剂研究技术指导原则缺失、《医疗机构制剂配制质量管理规范》不完善、《医疗机构制剂注册管理办法》不允许化学药制剂委托配制及部分化学药制剂品种已经不能适应新形势的发展等。完善医疗机构制剂相关法规和以安全有效为标准选择性发展医疗机构化学药制剂品种是解决思路。今后可从制定医疗机构化学药制剂研究技术指导原则、细化成品留样的规定、增加持续稳定性考察的规定、允许已有批准文号化学药制剂委托配制、淘汰不适应新形势发展的医疗机构化学药制剂品种并发展有价值的医疗机构化学药制剂品种等方面入手，为临床提供更多安全、有效的化学药制剂。
关键词 医疗机构化学药制剂;注册;问题;建议
Problems and Suggestions in the Registration and Approval of Chemical Preparations in Medical Institutions of Guangdong Province
CHEN Jiarun1，SHEN Xiaoli2，WANG Xiaoying1，JIANG Yingzhu1（1. Center for Evaluation and Certification， Guangdong Drug Administration， Guangzhou 510080， China; 2. Guangdong Food and Drug Vocational College， Guangzhou 510520， China）
ABSTRACT OBJECTIVE： To provide reference for ensuring clinical drug safety and promoting the development of characteristic chemical preparations in medical institutions. METHODS： From three aspects such as registration declaration of new preparations， supplementary application declaration and re-registration declaration， the problems found during the technical review of registration of chemical preparation in medical institutions of Guangdong province have been summed up， the causes of above problems also have been analyzed， and the relevant suggestions have been given at the same time. RESULTS & CONCLUSIONS： There were deficiencies in the registration declaration of new preparations， such as insufficient basis for the title， the lack of key process parameters in the study of preparation process and the failure of stability test conditions to meet the requirements of the Pharmacopoeia， etc. There were deficiencies in the supplementary application declaration， such as the ueasonable formulation of drug， the interaction between the drugs packing material and the drug， and ueasonable setting of storage conditions. There were deficiencies in the re-registration declaration， such as the supply of existing drugs on the market， the lack of production conditions for the formulation unit， the inability to purchase the original excipient materials， and the incomplete attention items. The main reasons were that the lack of technical guidelines for the research of chemical preparations， imperfection of the Standards for the Quality Management of Pharmaceutical Preparation in Medical Institutions and authorized preparation of chemical agents not allowed in Measures for the Registration and Administration of Pharmaceutical Preparation in Medical Institutions， and some kinds of chemical preparations could not adapt to the development of the new situation. The solutions are to improve the regulations of medicinal preparation in medical institutions and develop chemical preparations selectively based on safety and efficiency. In the future， the problems can be solved by formulating the technical guidelines for the research of chemical preparations in medical institutions， refining the rules for the retention of samples in finished products， increasing the requirements for continuous stability inspections， allowing authorized chemical preparations to be commissioned and prepared， phasing out the chemical preparations that do not adapt to the new situation， and developing valuable chemical preparations， to provide safe and effective chemical preparations for clinical use.
