Target Processing Timelines
The target screening and evaluation processing timelines for applications for therapeutic products are as follows:
The total screening timeline is defined as working days from date of receipt of application dossier to the date of acceptance or non- acceptance/withdrwal.
For NDA, GDA, MAV-1 and MAV-2 applications (full/abridged/verification), the screening timeline is 50 working days, excluding stop-clock.
Evaluation Timeline (excluding stop clock)
^MIV-1 applications - The target processing timeline starts from the date of receipt of the MIV-1 application in PRISM to the date of regulatory decision or withdrawal date, excluding stop-clock time.
^MIV-2 applications - Applicants can implement the proposed change(s) if HSA does not raise any objection within 40 working days from the date of submission of the complete dataset for the application
*All timelines stated (in working days) are subject to change
For more information please refer to Appendix 5: Target Processing Timelines of the Guidance on Therapeutic Product Registration.