Health Sciences Authority (Amendment) and Other Matters Bill Passed to Consolidate Health Regulatory Functions under HSA

On 9 September 2026, the Health Sciences Authority (Amendment) and Other Matters Bill (“Bill“) was passed by Parliament. The Bill establishes the Health Sciences Authority (“HSA“) as Singapore’s integrated health regulator and consolidates key health regulatory functions under a single authority.

Current Regulatory Ecosystem

Singapore’s regulatory framework is currently administered by various agencies including:

1. Ministry of Health (“MOH“), which oversees healthcare services, health information, human biomedical research and biosafety;
2. HSA, which regulates inter alia health products, including medicines and medical devices; and
3. The various Healthcare Professional Boards (collectively, “SPB“), responsible for regulating doctors, dentists, nurses, pharmacists and allied health professionals.

As the healthcare sector continues to evolve, emerging care models and technologies, including digital health, genomics and artificial intelligence, increasingly cut across multiple regulatory domains. There is a plan to consolidate relevant expertise and regulatory capabilities to facilitate a more coordinated approach to addressing patient safety and access issues throughout the healthcare journey.

Against this backdrop, the Bill seeks to establish an integrated regulatory framework under HSA by bringing together relevant health regulatory functions currently administered by different agencies.

Consolidated Structure: Three Key Benefits

The consolidated structure is intended to deliver three key benefits:

1. Greater clarity and certainty for industry stakeholders: Licensing applications, regulatory enquiries and other interactions will be administered through a single agency, enabling industry participants, innovators and healthcare providers to benefit from more coordinated guidance and greater regulatory certainty.

2. Stronger coordination across research and clinical care: A more cohesive approach to oversight across the research and clinical care continuum will provide clearer and more consistent guidance, strengthen safeguards for research participants, and facilitate the translation of research into clinical practice.

3. A unified point of contact for the public: Members of the public will benefit from a streamlined interface for raising concerns relating to health products, healthcare services and healthcare professionals.

MOH will continue to oversee Singapore’s healthcare system and formulate national healthcare policies to ensure that it remains safe, affordable, accessible and sustainable. HSA will, in turn, administer the integrated functions under the Bill in accordance with MOH’s policies and directions. 

Legislative Changes

To implement the integrated framework, the Health Sciences Authority Act 2001 will be amended to expand HSA’s functions in three key areas:

1. Research and biosafety oversight: HSA will assume responsibility from MOH for administering and enforcing the Human Biomedical Research Act and the Biological Agents and Toxins Act.

2. Administration and enforcement of healthcare legislation: HSA officers will support the Minister for Health and the Director-General of Health in the administration and enforcement of specified healthcare legislation, including the Healthcare Services Act and, once in force, the Health Information Act.

3. Professional regulation support: HSA will take over SPB’s role in supporting the Professional Boards and Councils in carrying out their regulatory mandates. The Boards and Councils will, however, continue to exercise their existing self-regulatory and disciplinary powers. 

Phased Implementation

The consolidation will take place in two phases to ensure a smooth transition and maintain regulatory continuity:

• Phase 1 (November 2026): MOH will transfer its regulatory functions and manpower to HSA.
• Phase 2 (by end-2027): SPB will complete the transfer of its functions and manpower to HSA.

Click on the following links for more information (available on the MOH website at www.moh.gov.sg):

• MOH Press Release titled “Health Sciences Authority (Amendment) and Other Matters Bill Passed to Consolidate Health Regulatory Functions”
• Health Sciences Authority (Amendment) and Other Matters Bill 2^nd Reading – Opening Speech by Mdm Rahayu Mahzam, Minister of State, Ministry of Digital Development and Information & Ministry of Health
• Health Sciences Authority (Amendment) and Other Matters Bill 2^nd Reading – Closing Speech by Mdm Rahayu Mahzam, Minister of State, Ministry of Digital Development and Information & Ministry of Health

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