China NMPA announced on 30th September that they would be accepting eCTD as an optional submission format for Initial NDA and BLA from 29th December 2021.
If the applicant chooses to submit an eCTD submission, they should also submit a paper copy of the submission within five working days of eCTD submission acceptance. The applicant also ensures that the dossier's content is consistent for both eCTD and paper by submitting a cover letter. As per the current guidelines, the other submission types (e.g., Variation) are not in the scope of eCTD, and NMPA has not mentioned any specific plan/timeline for expanding the range of eCTD for other submission types. However, NMPA is still working and plans to implement eCTD on a stepwise approach for all submission types, and more information will follow. The eCTD submission should be submitted on a CD/DVD to NMPA (Delivery Media), and NMPA is working to establish an eSubmission gateway; however, there is no official update.
If you are interested in learning more about eCTD submissions in China, we recommend watching our Webinar Recording: The Basics of eCTD Submissions in China.
EXTEDO's submission management solution, eCTDmanager, already supports the Chinese eCTD format. EXTEDO can also provide consulting, training, or publishing services for Chinese eCTD submissions. Just contact us if you need support.
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