Overview:
On September 29,2021, China Health Authority (NMPA) published the technical specifications of Electronic Common Technical Document (eCTD) for the initial New Drug Application (NDA) and Biologics License Applications (BLAs) that will come into effect by December 29, 2021.
China eCTD technical specifications refer to International Conference of Harmonization (ICH) specification 3.2.2, and the requirements are more reflective of the FDA’s eCTD specifications than to EMA’s eCTD process.
Key China eCTD Specifications
- Applicant submitting an eCTD dossier must also submit a paper copy of the submission within five (05) working days after the eCTD submission acceptance.
- Applicant must ensure while submitting a cover letter that the content of the dossier is consistent for both eCTD and paper submissions. Documents will be required in Mandarin with English versions as reference.
- The eCTD should be submitted on a CD/DVD to NMPA. The HA is working to establish an e-submission gateway. However, there is no official update on the same.
- Module 2 to Module 5 will follow the format requirements of ICH eCTD.
- The first sequence will be 0000, which deviates from the US requirement of 0001 for the current US 3.3 regional DTD.
- Current CDE validation specifications only require error and warning information and no prompt information. Validation of both English and Chinese documents is still to be resolved.
- China intends to provide a link to its official CDE website for eCTD validation, which will be free of charge.
OTHER SUBMISSION TYPES
As per the current guidelines, 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 scope for the same. The (HA) plans to implement eCTD as a stepwise approach for all submission types and more information will follow.
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