Singapore’s Ministry of Health (MOH) and Health Sciences Authority (HSA) announced on October 12 several measures to get new drugs and medical devices to patients faster. Starting in early 2027, clinical trial sponsors will get more hands-on help, including earlier regulatory consultations and clearer guidance, help finding investigators and trial sites, and one single standard template for trials across multiple hospitals. The approval timeline for some lower-risk Phase 3 trials could also drop by half, from 30 days to 15.
Reimbursement decisions should come faster as well. From November, a new priority track will let MOH’s Agency for Care Effectiveness (ACE) run its health technology assessment (HTA) at the same time as HSA’s regulatory review, rather than waiting for it to finish. For selected products, the first price decision is expected six to nine months after approval, down from about one year.
HSA’s regulatory role is also growing. Under a law passed on September 9, rules for AI-based devices, AI-enabled health services, and clinicians’ use of AI, which had been spread across separate laws, will come together under one new HSA law.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.