本文關(guān)鍵詞： 通用技術(shù)文件 質(zhì)量控制 化學(xué)仿制藥 注冊(cè)　出處：《浙江大學(xué)》2016年碩士論文　論文類型：學(xué)位論文

【摘要】：藥物注冊(cè)通用技術(shù)文件(Common Technical Document, CTD)是歐美日等ICH國(guó)家通行的化學(xué)藥品包括仿制藥注冊(cè)申請(qǐng)材料的規(guī)范格式文件。國(guó)家食品藥品監(jiān)督管理總局(China Food and Drug Administration, CFDA)于2010年9月25日正式發(fā)布了《化學(xué)藥品CTD格式申報(bào)資料撰寫要求》,該申報(bào)適用于《藥品注冊(cè)管理辦法》附件2化學(xué)藥品注冊(cè)分類3、4、5和6的生產(chǎn)注冊(cè)申請(qǐng)的藥學(xué)部分申報(bào)資料,即CTD格式模塊2的質(zhì)量相關(guān)綜述和模塊3的質(zhì)量相關(guān)文件。CTD格式化注冊(cè)申請(qǐng)文件的內(nèi)涵與藥品質(zhì)量控制的理念密切相關(guān),在化學(xué)仿制藥注冊(cè)申請(qǐng)中推廣應(yīng)用,可強(qiáng)化企業(yè)申請(qǐng)資料的規(guī)范性和系統(tǒng)性,提高注冊(cè)審評(píng)效率,有利于提升我國(guó)仿制藥研究水平、質(zhì)量保證能力和審評(píng)水平。本文以CTD格式文件為切入點(diǎn),詳細(xì)介紹了國(guó)內(nèi)外現(xiàn)行CTD格式文件模板的實(shí)踐情況,調(diào)研了我國(guó)CTD施行過(guò)程中出現(xiàn)的問(wèn)題和解決方案,以及對(duì)如何更好地與國(guó)際接軌進(jìn)行了研究和提出了改進(jìn)建議。首先,總結(jié)和分析人用藥物注冊(cè)技術(shù)要求國(guó)際協(xié)調(diào)會(huì)議(International conference on harmonization of technical requirements for registration of pharmaceuticals for human use, ICH)和我國(guó)CTD格式文件的要求和實(shí)施案例。其次,結(jié)合CTD格式文件應(yīng)用于仿制藥注冊(cè)的實(shí)踐,分析我國(guó)化學(xué)仿制藥注冊(cè)申請(qǐng)CTD格式文件的撰寫內(nèi)容和要求,并剖析國(guó)內(nèi)企業(yè)進(jìn)行國(guó)際注冊(cè)的模式和案例。最后,針對(duì)目前國(guó)內(nèi)CTD格式文件及其實(shí)踐中存在的問(wèn)題,通過(guò)對(duì)比國(guó)內(nèi)外對(duì)CTD格式文件各章節(jié)細(xì)節(jié)的要求,對(duì)進(jìn)一步改進(jìn)我國(guó)仿制藥CTD格式文件注冊(cè)申請(qǐng)制度進(jìn)行了探討,建議修訂和完善國(guó)內(nèi)CTD文件章節(jié),推行電子化的CTD注冊(cè)申報(bào)方式(eCTD),更好地與國(guó)際注冊(cè)接軌。通過(guò)本研究的論述,使藥品申報(bào)企業(yè)和管理者對(duì)CTD格式文件的研究?jī)?nèi)容和技術(shù)要求有充分了解,有利于推進(jìn)我國(guó)仿制藥按完整CTD格式文件進(jìn)行國(guó)內(nèi)外同步注冊(cè),促進(jìn)國(guó)內(nèi)申報(bào)與國(guó)際申報(bào)要求接軌,提升我國(guó)仿制藥研究的整體質(zhì)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.
【學(xué)位授予單位】：浙江大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R95

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