广东省药品注册申报存在的问题分析与建议

发布时间：2018-06-22 23:28

本文选题：药品注册 + 审批意见　；参考：《中国药房》2017年22期

【摘要】：目的:为药品注册申报提供参考。方法:收集2015年国家食品药品监督管理总局对广东省申报药品不予批准的审批意见,分析临床试验和注册生产两个阶段中药品注册申报存在的问题,并根据相关的政策法规提出建议。结果与结论:化学药申报临床试验阶段被退审的原因主要集中在已有进口药品注册申请批准或该新药进入监测期;而药学研究质量缺陷,特别是杂质、有关物质研究不充分是申报临床试验和申报生产中的主要问题。针对临床试验申报,申请人应适应新的药品注册分类改革,加强原始创新药物研制,生物制品开发应建立全面有效的生物制品评价体系,形成优势技术和产品;针对注册生产申报,相关部门或药物生产企业应加强对药品剂型和规格设计的合理性评价,仿制药应注重与原研药品的一致性评价。除此之外,还可通过建立科学可行的杂质、有关物质研究方法,注重前瞻性生产工艺的放大研究等解决上述问题。
[Abstract]:Objective: to provide reference for drug registration. Methods: to collect the opinions of the State Administration of Food and Drug Administration on the examination and approval of drug declaration in Guangdong Province in 2015, and analyze the problems existing in the two stages of clinical trial and registered production. And according to the relevant policies and regulations put forward suggestions. Results & conclusion: the reasons for the withdrawal of chemical drugs in clinical trials are mainly due to the application for registration of imported drugs or the entry of the new drug into the monitoring period, and the quality defects, especially impurities, in pharmaceutical research. Insufficient research on related substances is the main problem in clinical trials and production. According to the clinical trial application, the applicant should adapt to the new drug registration and classification reform, strengthen the original and innovative drug development, and establish a comprehensive and effective biological product evaluation system to form the superior technology and product. According to the registered production declaration, the relevant departments or drug manufacturing enterprises should strengthen the rational evaluation of drug formulation and specification design, and the generic drugs should pay attention to the consistency evaluation with the original drugs. In addition, the above problems can be solved by establishing scientific and feasible impurity, research methods of related substances, and paying attention to the study of prospective production process.
【作者单位】：广东省食品药品监督管理局审评认证中心;
【基金】：广东省食品药品监督管理局定向委托课题(No.许药-2016-01)
【分类号】：R951

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