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Health Sciences Authority
Regulatory Updates

Mean applicant screening response time

Audiences

Industry member

Product type

Therapeutic Products

31 October 2025

HSA’s target screening turn-around-time from the date of receipt of the application dossier to the date of acceptance or non-acceptance/withdrawal of the application (excluding applicant’s response time) is 50 working days (WD).

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

For the new and major variation applications accepted within the period of 01 Apr 25 to 30 Sep 2025, the mean screening time taken by HSA was 34.5 WD for NDA, 35.6 WD for GDA and 23.1 WD for MAV applications respectively.

Below are bi-annual updates of the mean applicant response time for the new and major variation applications:

Mean Applicant Response Time

Period


NDA

GDA

MAV

01 Apr 2025 to 30 Sep 2025

Number of applications

59

161

66

Mean Applicant Response Time (WD)

31.8

35.9

10.9

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