HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the new and major variation applications accepted within the period of 01 Apr 2022 to 30 Sep 2022, the mean screening time taken by HSA were as following:
– 33.3 WD for New Drug Application (NDA)
– 29.0 WD for Generic Drug Application (GDA), and
– 20.2 WD for (Major Variation) MAV application respectively.
For bi-annual updates of the mean applicant response time for the new and major variation applications, please refer to the following link: https://www.hsa.gov.sg/announcements/regulatory-updates/mean-applicant-screening-response-time”