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?
- Last updated：2024-08-27
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In principle, the submission timing is not restricted. For rejections, however, the following apply: 1. If the rejection is due to failing to meet the eligibility criteria, resubmission should be made as a standard case with recommendations for coverage after obtaining the approval letter from the Food and Drug Administration . 2. If the RTF (Refuse to File) is received from the Food and Drug Administration, on the other hand, the NHIA will reject parallel review for closed cases. 3. If the rejection is due to incomplete information in the administrative review by NHIA, the case can be resubmitted for parallel review with recommendations for coverage once the missing information is provided. (please enclose the Submission Notice upon fulfillment of eligibility requirements).