对《医疗机构制剂注册管理办法(试行)》有关问题的探讨

Discussion on Relevant Issues of Medical Institution Preparation Registration Management Approach(Trial)

目的:为完善医疗机构制剂注册法规、促进医疗机构制剂发展提供参考。方法:通过对《医疗机构制剂注册管理办法(试行)》内容进行梳理、总结和归纳,针对其在医疗机构制剂定义等方面存在的不足,提出相应的完善建议。结果与结论:《医疗机构制剂注册管理办法(试行)》自2005年颁布至今已12年,存在医疗机构制剂定义范畴过宽、注册申报资料要求不甚严谨、临床研究规定模糊不清、临床应用再评价工作不足、不予批准情形缺失等方面的不足。针对上述不足,笔者提出缩小医院制剂定义范畴、修改注册申报资料要求、明确临床研究规定、增加新制剂监测期及增订不予批准的情形等建议,从而完善医疗机构制剂注册法规、促进我国医疗机构制剂发展。

OBJECTIVE： To provide reference for improving registration regulation of medical institution preparation and pro- moting the development of it. METHODS： According to sorting out and summarizing the Medical Institution Preparation Registration Management Approach （trail） contents, for its shortcomings in terms of medical institution preparation definitions, related im- provement suggestions were put forward. RESULTS ＆ CONCLUSIONS： The Medical Institution Preparation Registration Manage- ment Approach （trail） has promulgated for 12 years from 2005 till now, existing shortcomings were that the definition of medical institution preparations was too wide, requirement on data of application and registration was less rigorous, regulation of clinical re- search was vague, clinical application re-evaluation was inadequate, disapproved case was lacked. In view of the above shortcom- ings, it is suggested to narrow the definition of medical institution preparations, modify the requirement on data of application and registration specify the regulation of clinical research, add monitoring period for the new preparation and update the disapproved case, so as to improve the registration regulation of medical institution preparations and promote the development of preparations in medical institutions.