In brief
On 12 October 2026, the Health Sciences Authority (HSA) 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) an ACE-HSA 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.
Recommended actions
Stakeholders should also monitor further details on the common entry point (to be launched in early 2027) and the Healthcare Industry Advisory Council (to be established in the first half of 2027).
In more detail
Regulatory innovation corridor with MHRA
As AI is increasingly applied throughout the drug-development lifecycle, HSA is strengthening its capabilities and developing regulatory guidance for the healthcare sector. The Regulatory Innovation Corridor will speed up patient access to breakthrough therapies, including those that use AI in drug development and clinical trials, by providing innovators with a coordinated pathway to engage with both regulators at the same time. This can help them plan ahead, design better clinical trials, avoid duplication and reduce delays. HSA and MHRA will also share regulatory approaches, advance regulatory innovation, and give innovators clearer and more predictable expectations across markets.
Common entry point and faster clinical trial approvals
Since July 2026, Enterprise Singapore, the Economic Development Board, HSA and the Singapore Clinical Research Institute have been working to coordinate a common entry point for clinical research and regulatory engagement in Singapore. This will be launched in early 2027 to provide more coordinated support for industry sponsors. Separately, HSA will streamline regulatory review processes, leading to faster approvals. For instance, approval times for selected lower-risk Phase 3 clinical trials may be halved from 30 days to 15 days.
ACE-HSA Priority Track
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.
Other developments
- Healthcare Industry Advisory Council – HSA will 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.
- World Health Organization’s (WHO) recognition – HSA became the first national regulatory authority in the world to attain the WHO highest Maturity Level (ML4) for medical devices regulatory systems in 2026, and is working towards the WHO Listed Authority status for vaccines.
- Integrated health regulator – Following the passing of the Health Sciences Authority (Amendment) and Other Matters Bill in September 2026, the Ministry of Health’s regulatory functions and manpower will be transferred to HSA on 1 November 2026, while the Secretariat of Healthcare Professional Boards’ functions and manpower will be transferred to HSA by end-2027.
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