China’s NMPA to improve NMPA CDE has released “Working Procedure for Accelerating the Review of Marketing Application of Innovative Drugs (Trial Implementation)”(hereinafter referred to as “Working Procedure”) for industry comments due March 4th, 2022.
A number of recent developments have made it possible to accelerate market access in China, and, in some cases, early access to pockets of the Chinese market even before the formal regulatory approval by the National Medical Products Administration (NMPA), which in turn helps with the approval process.
The new guideline applies to marketing application for innovative drugs as granted with breakthrough therapeutic designation.
The review time in the Working Procedure is shortened to 130 days (same as priority review).
1) Rolling submission
- The applicant can submit the dossier and query response on a rolling basis. The current practice is that sponsor can only submit one-time off for most of the cases.
2) Early engagement with review team:
- The CDE review team shall be set up earlier prior to the initiation of sponsor’s confirmatory clinical trial.
- The consultation meeting time shall be shortened to 30 working days from meeting request to implementation (compared to 60 working days as standard timeline).
3) Streamlined Inspection Readiness Procedure
- The applicant is encouraged to submit registration testing request before the formal application for marketing. If no registration test is submitted, a notice of analysis shall be issued at the time of acceptance, and the registration inspection task shall be completed within 10 days of acceptance.
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