Parallel review System (with reference to the questions and answers of the NHIA)
- 1 Q1. Do submissions of high-cost cancer drugs remain the same in parallel review categorization, even if it is still required to provide related information of high-cost cancer drugs?
- 2 Q2.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?
- 3 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?
- 4 Q4. Is it required to submit the proposal at this stage since eligibility review is added, which poses the primary difference from prior submissions?
- 5 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?
- 6 Q6. For the "Parallel Review Eligibility Documentation Checklist" for National Health Insurance coverage, what does "authorized to register" refer to in items 2 and 4?