Key initiatives include a new priority track, set to launch in November 2026, allowing selected health products to undergo simultaneous regulatory evaluation and health technology assessment. This aims to reduce assessment times significantly. Additionally, Singapore is establishing a "regulatory innovation corridor" with the United Kingdom to explore breakthrough therapies, including those utilizing artificial intelligence in drug development.
These efforts are expected to halve approval times for certain lower-risk Phase 3 clinical trials, reducing them from 30 days to 15 days. The time for the first health technology assessment decision could also be shortened from approximately one year to between six and nine months post-regulatory approval.
Minister Ong highlighted the need to simplify the journey for companies moving through research, clinical development, regulatory evaluation, and patient access, noting that current multi-agency hand-offs can cause delays and uncertainty. The HSA's regulatory approach is expanding across geographical boundaries, the healthcare value chain, and regulatory domains to create a more integrated system.
Singapore also seeks to leverage its regulatory approvals as a trusted gateway to larger regional markets, as many countries currently refer to HSA approvals to expedite their own processes. As part of the Access Consortium, Singapore aligns regulatory practices with other medium-sized regulatory authorities, sharing evaluation work and expertise. The nation is also pursuing World Health Organization listed authority status for vaccines, which could potentially speed up vaccine access while maintaining high safety standards.