In brief
On 11 June 2026, the Health Sciences Authority (HSA) published its latest mean applicant screening response times for new and major variation applications accepted between 1 October 2025 and 31 March 2026. HSA’s target screening turnaround time remains 50 working days from receipt of the application dossier to acceptance, non-acceptance or withdrawal, excluding applicant response time.
Key takeaways
The latest figures indicate that HSA continues to complete screening of new and major variation applications within its target timeline. The data also highlights the continued importance of timely applicant responses in managing overall product registration timelines.
In more detail
For applications accepted between 1 October 2025 and 31 March 2026, the mean screening time recorded by HSA was as follows:
- 35.4 working days for new drug applications (NDA)
- 36.2 working days for generic drug applications (GDA)
- 22.3 working days for major variation applications (MAV)
Separately, the bi-annual updates of the mean applicant response time for the new and variation applications, together with the number of applications, within the period of 1 October 2025 and 31 March 2026 are as follows:
- 29.3 working days for NDA (96 applications)
- 28.6 working days for GDA (108 applications)
- 12.1 working days for MAV (88 applications)
* * * * *
© 2026 Baker & McKenzie. Wong & Leow. All rights reserved. Baker & McKenzie. Wong & Leow is incorporated with limited liability and is a member firm of Baker & McKenzie International, a global law firm with member law firms around the world. In accordance with the common terminology used in professional service organizations, reference to a "principal" means a person who is a partner, or equivalent, in such a law firm. Similarly, reference to an "office" means an office of any such law firm. This may qualify as "Attorney Advertising" requiring notice in some jurisdictions. Prior results do not guarantee a similar outcome.