If A Registered Product Does Not Apply For Renewal Registration Within The Specified Time, Can The Original Registered Product Be Selected As The Predicate For Clinical Evaluation When Applying For A New Registration And How Should Clinical Data Be Provided?


In this case, the original registered product can be selected as the predicate to complete the clinical evaluation. The comparison of the predicate mainly focuses on whether there is difference between the product under application and the original registered product. If there is no difference, the available clinical data includes the pre-market and post-market clinical data of the product, and the clinical experience data containing the post-market adverse events.