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?-Health Technology Assessment

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Parallel review System (with reference to the questions and answers of the NHIA)
Health Technology Re-assessment Mechanism-related Issues
Coverage of Special Devices under National Health Insurance

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?

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Last updated：2024-08-27
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The manufacturer is responsible for providing evidence and should still submit the relevant documents when applying.

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?

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?