Singapore to pilot concurrent reviews for selected health products
Singapore’s ACE–HSA pilot begins with November/December 2026 pipeline scanning; selected firms may be invited from around August 2027 for concurrent reviews.
Singapore will introduce an ACE–HSA pilot in November 2026 to coordinate regulatory review and health technology assessment for selected health products. The first November/December window is for scanning company pipelines; ACE expects invitations to selected firms from around August 2027, before their assessments can run together. For companies planning an eligible treatment launch, that eventual overlap could narrow the wait between product approval and the first assessment of its clinical and economic value. The Health Sciences Authority (HSA) announced the plan with the Agency for Care Effectiveness (ACE) on 12 October.
The agencies call this the ACE–HSA Priority Track. Under the current sequence, companies typically wait a year or more for a first ACE health technology assessment decision after HSA regulatory approval. For selected company-led submissions under the pilot, ACE targets a first decision about six to nine months after approval. The agencies would share information and coordinate evaluation timelines, while making their regulatory and value-assessment decisions independently.
Which sponsors can enter the pilot?
The present scope covers therapeutic drugs and cell, tissue and gene therapy products. ACE says selection will weigh unmet clinical need, evidence for cost-effectiveness and value, Singapore health priorities, and a company's intention to commercialise locally. This makes the pilot a route for chosen products, rather than a new deadline for every medicine or therapy submitted in Singapore. Participation does not determine approval, a positive assessment or public funding.
ACE expects to scan companies' product pipelines in November and December 2026. Sponsors can provide information through that existing process; they need not file a separate Priority Track application. ACE says it will contact selected companies from around August 2027 and invite them into coordinated HSA regulatory review and ACE's company-led assessment process. Existing regulatory submissions can continue through ordinary HSA channels while selection is pending.
A separate clinical-trial review change
HSA also said approval time for selected lower-risk Phase 3 clinical trials may fall from 30 days to 15 days. That prospective review change concerns trial authorisation, not the ACE–HSA product-assessment clock. A common entry point for industry sponsors seeking clinical-research and regulatory engagement is planned for early 2027, another step separate from the November pilot.
The timing matters to sponsors assembling Singapore trial, registration and market-access plans: an eligible product could have two evaluations progressing together, but the six-to-nine-month interval remains a target measured after regulatory approval. ACE says the shorter interval also depends on companies submitting complete information for both evaluations on time.
Sources: HSA's 12 October announcement; ACE's Priority Track guide.
