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?
- Last updated：2024-11-22
- Count Views：848
As far as this is concerned, the manufacturer is asked to provide the data of the population with optimal cost-effectiveness upon submission. If the approved scope of application is narrower than that initially advised for NHI coverage, a re-submission is required for the manufacturer.
For Category 2 cases under parallel review, it is required to include supporting information from official websites to verify that the drug has not been approved globally at the time of applying for registration in our country. Since this information is already provided during the application to the Food and Drug Administration, can CDE directly reference the relevant data?
Is it required to submit the proposal at this stage since eligibility review is added, which poses the primary difference from prior submissions?