Singapore fast-tracks regulatory pathway to boost clinical research and AI-driven therapies

Singapore is positioning itself as a regional hub for clinical research by overhauling its regulatory framework, Health Minister Ong Ye Kung announced on Oct 12. A new priority track run by the Health Sciences Authority and the Agency for Care Effectiveness will allow selected health products to undergo simultaneous regulatory evaluation and health technology assessment. The government also unveiled a partnership with the United Kingdom to create a “regulatory innovation corridor” focused on breakthrough and AI-enabled therapies.

These reforms aim to reduce approval times for low-risk Phase 3 trials from 30 days to 15 days and shorten the first health technology assessment decision from about a year to six-to-nine months. Regulatory responsibilities previously split between the Ministry of Health and other bodies will be transferred to the Health Sciences Authority in two phases, completing by end-2027. Singapore is also seeking WHO listed authority status for vaccines to further accelerate access while maintaining safety standards.