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?-Health Technology Assessment

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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?

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Last updated：2024-08-27
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The so-called " authorized to register" is that referred to under applicable requirements of the Food and Drug Administration’s “Regulations for Registration of Medicinal Products” Therefore, applicable time points are calculated according to the timing of official acceptance of the case by the Food and Drug Administration while the manufacturer applies for registration.

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?