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This application is a service of the Singapore Government.

Health Sciences Authority

Target Processing Timelines

*All timelines stated (in working days) are subject to change

Applications for Therapeutic Products

Screening timeline

25 working days before the first communication, in the form of an Input Request or acceptance/non-acceptance notification, is issued

Evaluation timeline

Dossier type

NDA

GDA

MAV-1

MAV-2

MIV-1

Full

270

 

270

   

Abridged

180

240

180

180

120

Verification

60

120

60

   

Verification – CECA

 

90

     

MIV-2 applications

Applicant 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.

For more information please refer to Appendix 5: Target Processing Timelines of the Guidance on Medicinal Product Registration.