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随着信息技术和制药行业的发展,eC TD逐渐成为全球药品注册申报文件的主流格式,尤其是在ICH国家和地区。2015年,国家食品药品监督管理总局强调了在我国建立统一的注册申请规范、全面实施CTD格式以及逐步推行eC TD电子递交的重要性。本文对ICH国家实施推行eC TD的经验进行汇总分析,同时总结我国目前的法规实施现状。通过问卷调查,对我国实施eC TD电子递交的可行性进行分析,分析推行过程中可能面临的问题和挑战,进而提出相应的政策建议。文中我国eC TD实施策略的研究成果,可以为制药行业开展事前准备提供参考,也可为监管机构政策制定提供依据。
With the development of information technology and pharmaceutical industry, eC TD has gradually become the mainstream format of the global drug registration declaration documents, especially in ICH countries and regions. In 2015, the State Food and Drug Administration stressed the importance of establishing a unified registration application specification in our country, implementing the CTD format in an all-round way, and gradually implementing eC TD electronic submission. This article summarizes the experiences of ICH countries in implementing eC TD and at the same time summarizes the current status of the implementation of laws and regulations in China. Through the questionnaire survey, this paper analyzes the feasibility of implementing eC TD electronic delivery in our country, analyzes the problems and challenges that may be faced in the process of implementation, and then puts forward the corresponding policy recommendations. The research results of eC TD’s implementation strategy in this paper can provide references for the pharmaceutical industry to prepare in advance, and also provide the basis for the formulation of regulatory agency policy.