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.

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.

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)

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