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This application is a service of the Singapore Government.

Health Sciences Authority

Target Processing Timelines

The target screening and evaluation processing timelines for applications for therapeutic products are as follows:

Screening timeline 

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)


Full 270 - 270 - - -
Abridged 180 240 180 180 120 40^
Verification 60 120 60 - 90 -
Verification-CECA - 90 - - - -

^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.