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日本药品注册收费标准评介及其对我国完善相应收费制度的启示
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篇名: 日本药品注册收费标准评介及其对我国完善相应收费制度的启示
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摘要: 目的:为完善我国药品注册收费制度,进而促进药品注册工作效率和质量的提高提供参考。方法:对比日本与我国药品注册审评工作实施概述(注册机构、流程、周期等),评介日本药品注册制度的收费标准并分析其特点,从而提出对我国药品注册收费标准的改革建议。结果与结论:日本的药品注册是由独立行政法人医药品医疗器械综合机构(PMDA)为主体、结合外部专家意见进行的内部审评,其对注册周期有严格的控制标准;收费标准按照新药注册、药品再注册,第一次申请、延展性申请,第一类医药品或第二类医药品、孤儿药或非孤儿药等制定了具体的收费金额,具有收费标准分类明确、收费金额普遍较高、收费水平与药品种类紧密相关等特点。而我国药品注册申请步骤更烦琐,涉及不同级别的相关机构和人员更多,且未对注册周期进行严格限定;收费标准制定较为粗略、收费金额较低、收费分类不够细致。建议我国借鉴日本药品注册收费标准的制定和管理经验,通过在药品审评中心年度报告中增加药品注册收费标准、提高收费金额、细分收费项目、设置反馈机制等措施完善我国现有的药品注册收费制度,为提高我国药品注册的效率和质量打下坚实基础。
ABSTRACT: OBJECTIVE: To provide reference for improving the charge system of drug registration in China so as to promote work efficiency and quality of drug registration. METHODS: Through comparing the implementation of drug registration and evaluation in Japan and China (registration institution, process, cycle, etc.), Japanese charge standard of drug registration system was evaluated and its characteristics were analyzed, so as to put forward the suggestion for charge standard reform of drug registration in China. RESULTS & CONCLUSIONS: Japanese drug registration was internal review, with the independent administrative institution Pharmaceuticals and Medical Devices Agency (PMDA) as main body, combined with the opinions of the external experts; there was a strict control standard for the registration cycle. Specific fee was confirmed by the charge standard according to new drug registration, drug re-registration, first application, extension application, first or second category of drugs, orphan drugs or non-orphan drugs. Japanese charge standard was characterized with clear classification of charge standard, high fees, close relationship of charge level with drug types. The procedures for drug registration were more cumbersome in China, and involved more relevant institutions and personnel at different levels; there was not strict restriction on registration period; relatively rough charge standard, low fee and not detailed charge classification also existed. It is suggested to draw lessons from the experience for charge standard formulation and management of drug registration in Japan, improve the current drug registration charge system in China by adding charge standard of drug registration into annual report of Center for Drug Evaluation, raising the amount of fee, subdividing the charge items and setting up the feedback mechanism, which lay a solid foundation for improving the efficiency and quality of drug registration in China.
期刊: 2018年第29卷第12期
编辑: 褚淑贞,陆倩妮,席晓宇
AUTHORS: CHU Shuzhen,LU Qianni,XI Xiaoyu
关键字: 日本;中国;药品注册;收费制度;收费标准
KEYWORDS: Japan; China; Drug registration; Charge system; Charge standard
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