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?
- Last updated：2024-11-22
- Count Views：910
If a parallel review case involves high-cost cancer drugs, that is, drug expenditure of any single year exceeds NT$ 500 million, existing submission principles need to be followed for submission of related necessary data.
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?