Do These Periodic Evaluations Need To Be Submitted To NMPA, Similar To A Normal Regulatory New Product Or Change Market Submission?

As of today, we don’t know the answer. But we believe, for periodic updates, this is the process you must follow the new regulation. In our best understanding, you may not need to submit the periodic clinical evaluation report. But in the future, if the agency wants to audit it, you should have these documents already in place. You should have the procedure and documentation in place. But definitely, for the registration of new products or making significant changes to existing products, you need to submit the clinical evaluation report.