Potential CDE submission pilot

[lengning]

Roche Shanghai colleague mentioned that CDE (china FDA) is initiating their own eCTD portal and recently a software for submission format validation was shared to sponsors for testing.

R consortium may consider reused the pilot 1 package and test it using the CDE esub package validation software

Given what we provided in the pilot1, sounds like converting it to a CDE esub package would be very doable. The main additional work would be translating the data sets and documents to Chinese (Roche China colleagues are happy to help, other R consortium WG members can help review)

Once the translation is finished, we can run the format validation software, and see whether it gives any red flags

After passing the formatting check, ideally we would love to engage CDE staff to review the submission package and rerun the R codes in the submission package.

If anyone has connections in CDE that may direct us to the appropriate CDE group to perform the review, please let us know

Thanks in advance!