Health Sciences Authority Strengthens Local and Global Partnerships to Accelerate Healthcare Innovations

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) 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. They were announced at the opening of the inaugural Health Regulatory Conference 2026 on 12 October 2026.

2       Speaking at the event, Guest-of-Honour Mr Ong Ye Kung, Minister for Health and Coordinating Minister for Social Policies, outlined how HSA’s regulatory approach is expanding across geographical boundaries, the healthcare value chain and regulatory domains. By working with industry, healthcare institutions and professionals as well as international partners, HSA aims to reinforce and strengthen the healthcare ecosystem and establish Singapore’s position as a trusted regulatory hub, and thus help beneficial innovations reach patients sooner.

Trusted Regulator and Gateway to Global Markets

3       HSA is internationally recognised as a trusted regulator and reference agency. It became the first national regulatory authority in the world to attain the World Health Organization's (WHO) highest Maturity Level (ML4) for medical devices regulatory systems in 2026. HSA also holds WHO's highest recognition for medicines regulatory systems, the WHO Listed Authority, and is recognised as a WHO Stringent Regulatory Authority for high-risk in-vitro diagnostics. Singapore is also a member of the Access Consortium, alongside Australia, Canada, Switzerland and the United Kingdom, that aligns regulatory practices, shares the work of evaluating therapeutic products and makes better use of scarce expertise.

 
4       Building on these achievements, HSA is working towards the WHO Listed Authority status for vaccines — the highest level under the WHO's regulatory benchmarking framework. This is critical to Singapore’s pandemic prevention, preparedness and response efforts, potentially speeding up access to vaccines while maintaining high safety standards.

 
Building Capabilities and Strengthening the Healthcare Ecosystem to Future-proof Regulation

 
5       As AI is increasingly applied throughout the drug-development lifecycle, HSA is strengthening its capabilities and developing regulatory guidance for the healthcare sector. To support innovators in this rapidly evolving field, HSA has partnered with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) to establish a Regulatory Innovation Corridor. This 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.
 
6       Singapore will also strengthen support across the healthcare value chain, from clinical development and regulatory evaluation to health technology assessment and patient access. Since July 2026, Enterprise Singapore, the Economic Development Board, HSA and the Singapore Clinical Research Institute (SCRI) 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. This strengthens Singapore's attractiveness as a clinical trials hub.
 
7       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. (Refer to www.go.gov.sg/ace-hsa-priority-track ↗ (opens in new tab) for more information on ACE-HSA Priority Track).

8       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.

9       Together, these initiatives create a faster, more coordinated journey from innovation to care - giving innovators earlier guidance, reducing duplication and helping to bring promising innovations sooner to more patients.

Growing Singapore’s Healthcare Ecosystem as an Integrated Health Regulator

10       To ensure that Singapore keeps pace with evolving healthcare delivery models, advances in medical technology, and changing population needs, the nation’s health regulatory functions will now come under HSA. This was passed in Parliament under the Health Sciences Authority (Amendment) and Other Matters Bill in September 2026. This positions HSA as a regulator that can build a more coherent, future-ready system that protects patients, provides clarity and predictability for healthcare industry and professionals, while enabling timely access to beneficial healthcare innovations.

11       HSA's development as an integrated regulator will be guided by four priorities: connecting expertise around the whole healthcare journey; anticipating change and regulating in proportion to risk; learning across the system to identify risks, act earlier and address issues upstream; and building people and partnerships that make integration work.

12       The consolidation will take place over two phases. In the first phase, the Ministry of Health’s regulatory functions and manpower will be transferred to HSA on 1 November 2026, while the Secretariat of healthcare Professionals Board’s (SPB) functions and manpower will be transferred to HSA by end-2027 in the second phase. More details about HSA’s role as an integrated regulator can be found here ↗ (opens in new tab).

13       HSA will continue to work with local and international partners on Singapore's regulatory approach to accelerate and strengthen access to healthcare innovations, while maintaining appropriate safeguards for patients and the public.

(Refer to Annex for Infographic)

HEALTH SCIENCES AUTHORITY
SINGAPORE
12 OCTOBER 2026

ANNEX