Mean applicant screening response time
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).
For the new and major variation applications accepted within the period of 01 Apr 2023 to 30 Sep 2023, the mean screening time taken by HSA was 30.0 WD for NDA, 29.8 WD for GDA and 21.6 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 2023 to 30 Sep 2023
|
Number of applications
|
57
|
108
|
56
|
|
Mean Applicant Response Time (WD)
|
37.7
|
42.2
|
16.6
|
Industry member, Therapeutic Products
Published:
Regulatory Updates