关键词: 药品注册, 电子递交, 通用技术文件, eCTD, CTD

Abstract:

With the development of information technology and pharmaceutical science, eCTD (electronic common technical document) has gradually become the main format for pharmaceutical registration dossiers all over the world, especially the ICH (the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) countries. In 2015, CFDA (China Food and Drug Administration) emphasized the significance of establishing a uniform specification for registration applications, extensively applying CTD format in China and enforcing eCTD electronic submissions step by step. In this study, we summarized the international experiences on implementation of eCTD from ICH countries and analyzed China’s current regulatory status. A survey was carried out to investigate the feasibility of implementing eCTD electronic submission in China, the possible problems to be faced with and the related solutions. Finally, recommendation on eCTD implementation strategy in China was proposed.

Key words: Registration application, Electronic submission, Electronic common technical document, eCTD, CTD