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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 (excluding stop-clock)

    

 

Dossier type  

 NDA GDA MAV-1 MAV-2 MIV-1 MIV-2

Total screening timeline*

Full/Abridged/

Verification

50 50 50 50 - -
Time to first communication# Verification-CECA - 14 - - 25

*Working days from date of receipt of application dossier to date of acceptance or non-acceptance/withdrawal 

#Working days from date of receipt of application dossier to date of acceptance, input request or non-acceptance/withdrawal

Evaluation Timeline (excluding stop clock)

Dossier
type

NDA   GDA MAV-1 MAV-2 MIV-1 MIV-2
Full 270 - 270 - - -
Abridged 180 240 180 180 120 40^
Verification 60 120 60 - 90 -
Verification-CECA - 90 - - - -
^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.