Singapore: HSA Outlines Direction as Integrated Regulator

In brief On 12 October 2026, the Health Sciences Authority (HSA) outlined its direction for the various health regulatory functions that is being integrated under HSA. This follows the passing of the HSA (Amendment) and Other Matters Bill (“ Bill ”) in September 2026, which brings the various health regulatory functions under HSA.

Further details have been shared in our previous alert “Singapore: Amendment to Consolidate Health Regulatory Functions”. In more detail Currently, the Ministry of Health’s (MOH) oversees healthcare services, health information, human biomedical research and biosafety; HSA regulates health products; and the Secretariat of Healthcare Professional Boards supports the Boards and Councils regulates healthcare professionals.

HSA noted that this model has served Singapore well, but complex cases increasingly challenge and cross these boundaries. For example, the safe use of AI in healthcare will require coordinated oversight of the product, care setting, professional practice and health information. Under the Bill, MOH’s regulatory functions and manpower will transition to HSA on 1 November 2026, followed by the administrative and operational functions supporting the Healthcare Professional Boards and Councils by the end of 2027.

MOH will continue to set national health policy and steward Singapore’s healthcare system, while HSA will bring together the consolidation of the various regulatory functions and streamlining of the processes and workflows to better support the stakeholders and safeguard the public.

HSA’s strategic direction The consolidation creates the foundation for four outcomes: Connecting expertise around the whole healthcare journey – HSA will strengthen both horizontal integration to coordinate the right response and identify any cross-cutting risks, and vertical depth to bring rigorous regulatory science and research, clinical, legal and professional expertise to address difficult questions.

Anticipating change and responding proportionately – HSA will move regulation upstream, including through horizon scanning, engagement with researchers, clinicians, industry and patients, and using regulatory sandboxes to test new models safely. Oversight will also continue to learn and respond to real world evidence.

Learning across the system – HSA will connect signals (e.g., a product incident, inspection finding and professional complaint) across regulatory domains to shape clearer guidance, targeted education and earlier engagement. Information should be shared only where appropriate, with clear controls and proper safeguards for confidentiality and data protection.

Building people and partnerships across the ecosystem – For selected high-priority products, HSA will bring the right partners around innovators, including start-ups, from clinical development and evidence generation through to product application, health technology assessment and adoption.

International regulatory cooperation and reliance (e.g., the regulatory innovation corridor with overseas regulators) can also help innovators use Singapore as a launchpad into priority regional and global markets. Over the coming decade, HSA hopes for stakeholders to experience a regulator that is clearer, more connected and more responsive: Innovators and researchers should have a clear entry point and, for selected high-priority products, coordinated support from clinical development and early-phase trials through product application, Health Technology Assessment (HTA), adoption and priority global markets.

Healthcare professionals and institutions should have clear expectations for scope of practice, competency, accountability and clinical service and information governance. Industry should find requirements easier to navigate, with coordinated guidance and clearer routes from Singapore to regional and global markets.

Patients should ultimately gain timely access to innovations, with confidence in its safety and effectiveness. HSA will also establish an Industry Advisory Council to provide a regular forum for HSA to consult the industry, test emerging issues and co-create practical solutions. Key takeaways Entities regulated under the affected healthcare regulatory regimes should take note of the transition of the Ministry of Health’s (MOH) regulatory functions and manpower to HSA on 1 November 2026, and monitor further guidance from HSA, particularly where their activities engage multiple regulatory domains. © 2026 Baker & McKenzie.

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