In brief
On 9 September 2026, the Health Sciences Authority (Amendment) and Other Matters Bill was tabled for Second Reading in Parliament. The Bill proposes to consolidate health regulatory functions and establish an integrated health regulatory function under the Health Sciences Authority (HSA).
In more detail
Currently, the regulatory ecosystem is organised across three different agencies:
- The Ministry of Health (MOH) regulates healthcare services, health information, human biomedical research and biosafety.
- HSA regulates health products such as medicines and medical devices.
- The Secretariat of Healthcare Professional Boards (SPB) supports the healthcare Professional Boards and Councils that oversee the regulation of doctors, dentists, nurses, pharmacists, and allied health professionals.
As healthcare evolves rapidly, new models of care and innovative technologies, such as digital health, genomics and artificial intelligence, may span various regulatory domains, and complex cases may require multiple regulatory touchpoints to address patient safety and access issues. Against this backdrop, the Bill proposes to consolidate these health regulatory functions under HSA, establishing HSA as Singapore's integrated health regulator.
Under the consolidated structure, there will be three key benefits:
- Greater clarity and predictability for industry, innovators and healthcare providers – an integrated regulator will allow licensing applications and enquiries to be managed by one agency, making information and responses more coordinated and clearer for stakeholders.
- Greater regulatory alignment across the research and clinical care continuum – Researchers and clinicians across the research and clinical care continuum will experience clearer and more consistent guidance upstream, thereby strengthening protection for research participants while providing a clearer pathway from research to eventual clinical application.
- Streamlined interface for the public – Members of the public will have a streamlined interface with the regulator, whether they have concerns about a medicine they have purchased, a medical device used in their care, or the healthcare service provider or professional caring for them.
MOH will continue to be responsible for stewarding Singapore’s healthcare system, including national healthcare regulatory policies, while HSA will undertake and execute the integrated regulatory functions within the scope of the Bill.
The consolidation will take place over two phases. MOH’s regulatory functions and manpower will be transferred to HSA in November 2026 in the first phase, while SPB's functions and manpower will be transferred to HSA by end-2027 in the second phase.
Key takeaways
Entities regulated under the affected healthcare regulatory regimes should take note of the phased transfer of regulatory functions to HSA, commencing with MOH's regulatory functions in November 2026 and followed by SPB's functions by end-2027. Businesses should review their existing regulatory touchpoints and monitor further guidance regarding the transition, particularly where their activities engage multiple regulatory regimes.
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