Q4. Is it required to submit the proposal at this stage since eligibility review is added, which poses the primary difference from prior submissions?
- Last updated:2024-08-27
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For parallel review cases, the CDE only notifies the manufacturer to submit the proposal after eligibility review is completed; for ordinary cases, the manufacturer needs to submit the payment proposal in the very beginning, which is consistent to the current procedure.
Q3. Regarding parallel review, if it is found by CDE that the scope of application for the proposed NHI coverage of the manufacturer exceeds or differs from that shown on the drug permit, will there be a reminder?
Q5. If a parallel review case is rejected or closed early, what will be the required interval before it is submitted for review again? Will the process revert to the standard review process?