Pre-submission Supplementary Notice Vs. Post-submission Supplemental Notice


When you submit the registration dossier to NMPA, the reviewer will perform a preliminary review. You will likely receive a pre-submission supplementary notice at this stage. It is also expected that you will receive several pre-submission requests until the reviewer thinks you are eligible for official submission acceptance. There is no due date for addressing the pre-submission requests. After official acceptance, you need to pay the application fee, and the first-round technical review will be performed. After several months, you will receive post-submission supplemental notice from the reviewer, for which you will have one-year time limit to address all the issues.
Takeaway: The reviewer who performs the pre-submission review is the same reviewer for the official technical review. As per NMPA statistics, an applicant receives 2.73 pre-submission supplemental notices on average.