CTD格式文件在化学仿制药注册中的实践和改进

发布时间：2018-01-31 09:49

本文关键词： 通用技术文件质量控制化学仿制药注册　出处：《浙江大学》2016年硕士论文　论文类型：学位论文

【摘要】：药物注册通用技术文件(Common Technical Document, CTD)是欧美日等ICH国家通行的化学药品包括仿制药注册申请材料的规范格式文件。国家食品药品监督管理总局(China Food and Drug Administration, CFDA)于2010年9月25日正式发布了《化学药品CTD格式申报资料撰写要求》,该申报适用于《药品注册管理办法》附件2化学药品注册分类3、4、5和6的生产注册申请的药学部分申报资料,即CTD格式模块2的质量相关综述和模块3的质量相关文件。CTD格式化注册申请文件的内涵与药品质量控制的理念密切相关,在化学仿制药注册申请中推广应用,可强化企业申请资料的规范性和系统性,提高注册审评效率,有利于提升我国仿制药研究水平、质量保证能力和审评水平。本文以CTD格式文件为切入点,详细介绍了国内外现行CTD格式文件模板的实践情况,调研了我国CTD施行过程中出现的问题和解决方案,以及对如何更好地与国际接轨进行了研究和提出了改进建议。首先,总结和分析人用药物注册技术要求国际协调会议(International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH)和我国CTD格式文件的要求和实施案例。其次,结合CTD格式文件应用于仿制药注册的实践,分析我国化学仿制药注册申请CTD格式文件的撰写内容和要求,并剖析国内企业进行国际注册的模式和案例。最后,针对目前国内CTD格式文件及其实践中存在的问题,通过对比国内外对CTD格式文件各章节细节的要求,对进一步改进我国仿制药CTD格式文件注册申请制度进行了探讨,建议修订和完善国内CTD文件章节,推行电子化的CTD注册申报方式(eCTD),更好地与国际注册接轨。通过本研究的论述,使药品申报企业和管理者对CTD格式文件的研究内容和技术要求有充分了解,有利于推进我国仿制药按完整CTD格式文件进行国内外同步注册,促进国内申报与国际申报要求接轨,提升我国仿制药研究的整体质量。
[Abstract]:Common Technical Document. CTDs are the standard format documents for the application materials for the registration of chemical products, including generic drugs, which are commonly used in ICH countries such as Europe, America, Japan and other countries.State Administration of Food and Drug Administration (. China Food and Drug Administration. In September 25th 2010, CFDAs officially released the requirements for the writing of the declaration materials in the CTD format of chemicals. This declaration is applicable to the pharmaceutical part of the application for registration of chemical drugs in the application for production registration in Annex 2, Category 3, 4, 5 and 6 of the measures for the Administration of Drug Registration. That is, the quality correlation of CTD format module 2 and the quality related file of module 3. CTD format registration application file is closely related to the concept of drug quality control. It can strengthen the standardization and systematization of enterprise application data, improve the efficiency of registration evaluation, and promote the research level of generic drugs in China. Quality assurance ability and evaluation level. This paper takes the CTD format file as the starting point and introduces the practice of the current CTD format file template at home and abroad in detail. This paper investigates the problems and solutions in the implementation of CTD in China, and makes a study on how to better connect with the international system and puts forward some suggestions for improvement. International Coordinating meeting to summarize and analyse Technical requirements for Registration of Human Drug use (. International conference on harmonization of technical requirements. For registration of pharmaceuticals for human use. ICH) and China's CTD format file requirements and implementation cases. Secondly, combined with the CTD format file is applied to the practice of generic drug registration. This paper analyzes the writing contents and requirements of CTD format files for registration of chemical generic drugs in China, and analyzes the modes and cases of international registration of domestic enterprises. Aiming at the problems existing in the domestic CTD format file and its practice, this paper compares the requirements of each chapter of the CTD format file at home and abroad. This paper discusses how to improve the application system for registration of CTD format files of generic drugs in China, and suggests to revise and perfect the chapters of domestic CTD documents and to implement the electronic CTD registration and declaration method. Through the discussion of this study, the enterprises and managers of drug application can have a full understanding of the research content and technical requirements of CTD format files. It is beneficial to promote the domestic and international registration of generic drugs according to the complete CTD format file, to promote the integration of domestic application and international declaration requirements, and to improve the overall quality of the research on generic drugs in China.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R95

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