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The Health Sciences Authority (HSA) in Singapore has announced three initiatives to help promising healthcare innovations reach patients sooner: (i) collaboration with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) through the Regulatory Innovation Corridor on regulatory considerations for breakthrough therapies that use Artificial Intelligence (AI) in drug development and clinical trials; (ii) a common entry point for clinical research and regulatory engagement in Singapore; and (iii) a HSA-Agency for Care Effectiveness (ACE) Priority Track that will allow selected health products to undergo regulatory evaluation and health technology assessment concurrently.
The initiatives could halve approval times for selected lower-risk Phase 3 clinical trials from 30 days to 15 days and shorten the time for the first health technology assessment decision from about one year to six to nine months after regulatory approval.
From November 2026, HSA and the Agency for Care Effectiveness (ACE) will introduce an ACE-HSA Priority Track for selected innovative health products, allowing regulatory evaluation and health technology assessment to be conducted concurrently rather than sequentially. Doing so could shorten the time needed for the first health technology assessment decision from about one year to six to nine months after regulatory approval. Regulatory and health technology assessment decisions will remain independent, and existing high standards for safety and clinical effectiveness will not change.
HSA will also establish a Healthcare Industry Advisory Council in the first half of 2027, to bring partners with industry experience to be directly involved in its future planning. The Council will identify emerging opportunities and risks, advise on future capability needs, and provide practical industry perspectives on policy and service design.
