The SFDA issued “Requirements on Application Dossiers in Common Technical Document (CTD) Format for Pharmaceutical Products” in late September 2010.
The release of this CDT format for Pharmaceutical Registration Applications continues China’s trend of integrating with international regulatory standards. Through further integration, greater quality of research and development in China’s drug sector is expected.
The drug CDT requirements drew significantly from the Common Technical Document (CTD) from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
As an addendum to this release, the SFDA has included some key points to note. Most importantly, Attachment 2 of “Provisions for Drug Registration” SFDA Order No. 28 must still be referenced. The SFDA appears to be presenting the CTD as a secondary format at the moment. In other words, applicants may consult the CTD for registration application sections for drug registration in China, but Attachment 2 of “Provisions for Drug Registration” will be the primary guideline. For example, application sections 3, 4, and 5 on manufacturing in Attachment 2 of “Provisions for Drug Registration” can be met by using the CTD format. However, the SFDA will not accept clinical trials sections in CDT format.
“Requirements on Application Dossiers in Common Technical Document (CTD) Format for Pharmaceutical Products”(Chinese) can be downloaded on China’s SFDA website. The Chinese version of Attachment 2 of “Provisions for Drug Registration” SFDA Order No. 28 can also be accessed on the SFDA website.