Practice And Improvement On The Common Technical Document(CTD) Regulatory Dossier For Generic Drugs

Common Technical Document(CTD) is the official format for chemical drug registration including generic drug in the ICH regulatory bodies of the European Union, Japan and USA. China Food and Drug Administration(CFDA) formally issued the declaration of writing requirements for pharmaceutical products CTD format on September 25th,2010. This declaration was applicable to the pharmaceutical part of the production application for 《DRUG REGISTRATION REGULATION)) attachment 2 chemical drug registration category 3,4,5, and 6. Namely, the CTD format presented a review of the quality related documents for module 2 and module 3. CTD format registration filing promotion was closely related to the concept of drug quality control. Its application in the field of chemical generic drugs registration improved the registration efficiency for generic drugs. And this revolution can also improve the level of generic drug research in China. The quality assurance ability and level of review can be improved too.Based on the CTD format file, we investigated the practice of current domestic CTD format document template in domestic and abroad.First of all, this paper investigated the requirements and progress of CTD format file of ICH and in China.Secondly, combining with the CTD format file applied in the practice of the generic drug registration, this paper investigated how to write a detailed registration CTD format file for the domestic pharmaceutical generics. And we also analyzed the model and cases of international registration for domestic enterprises.Finally, aiming to the problems existing in the domestic CTD format file, and comparing the different requirements of chapters detail in domestic and abroad, this paper analyzed how to improve the generic CTD format file registration, also suggested revising and completing domestic CTD file section. Then to match the international registration, we should promote eCTD electronic submission.Through this research, we made that drug enterprises and managers understand the CTD format file of the research content and technical requirements fully. We hope that generic drugs will be registered according to the complete CTD format file in domestic and abroad synchronically, and the revolution of CTD can improve the overall quality of the generic drug research in China.