Ong Ye Kung Outlines Singapore’s Strategy to Strengthen Health Regulation and Biomedical Growth

Singapore’s approach to health regulation is evolving beyond patient safety to support biomedical innovation and economic development. Speaking at the 29th Session of the International Medical Device Regulators Forum, Health Minister Ong Ye Kung described how the Health Sciences Authority (HSA) is strengthening its international standing, updating regulatory frameworks for emerging technologies such as artificial intelligence (AI), and working across government to support the growth of the biomedical sector while safeguarding public health.

The speech, delivered at the international forum, placed HSA’s work within Singapore’s broader healthcare and economic strategy, emphasising trust, regulatory credibility and international cooperation as core public assets.

HSA’s expanding role in healthcare and regulation

Mr Ong highlighted HSA’s track record in responding to complex public health challenges. During the COVID-19 pandemic, the agency authorised vaccines under the Pandemic Special Access Route despite incomplete datasets, enabling Singapore to deploy vaccines quickly while managing clinical risk. More recently, HSA developed enforcement capabilities to regulate e‑vaporisers containing etomidate, an area outside its traditional remit.

These experiences, he said, demonstrate HSA’s ability to combine clinical judgement, regulatory oversight and enforcement. Building on this foundation, the agency is now taking on a more explicit economic role by supporting the development of Singapore’s biomedical and medical technology ecosystem.

Healthcare, research and economic development

Singapore has deliberately prioritised affordable and accessible care for its population over medical tourism. While this limits direct economic returns from clinical services, the wider healthcare ecosystem plays a significant role in growth through research, clinical development and manufacturing.

Total research and development spending in Singapore is about 2% of gross domestic product each year, supported in part by the Research, Innovation and Enterprise 2030 plan, which allocated S$37 billion (approximately US$29 billion) over five years. Human health and biomedical sciences are a key focus, supported by universities, public hospitals and the Agency for Science, Technology and Research.

Singapore is also an established site for industry-sponsored clinical trials, with around 100 new trials starting annually. Although the country’s population is small, its diverse patient mix and trusted regulatory environment allow participation in international, multi-centre trials.

Manufacturing strength and global supply chains

Biomedical manufacturing is another pillar of Singapore’s healthcare-linked economy. Biopharmaceutical manufacturing output reached S$13.9 billion in 2023, while medical technology manufacturing grew to about S$18.9 billion. Most production is for export, supported by skilled labour, strong intellectual property protection and extensive free-trade agreements.

During the COVID-19 pandemic, Singapore-based manufacturers continued to honour export contracts despite global shortages, reinforcing confidence in the country as a reliable production base for international markets.

Positioning Singapore as a global regulatory reference

A central theme of the speech was HSA’s growing role as an international reference authority. The agency has achieved the World Health Organization’s highest maturity level for medicines and medical devices and has been recognised as a WHO Listed Authority. For high-risk in vitro diagnostics, HSA is also recognised as a WHO Stringent Regulatory Authority.

As a result, regulators in jurisdictions including Australia, Hong Kong, Malaysia, the Philippines, Thailand and the United Kingdom reference HSA decisions to expedite their own approval processes. Singapore is also a member of the Access Consortium, which aligns regulatory practices with partners such as Australia, Canada, Switzerland and the United Kingdom to reduce duplication and speed patient access to therapies.

A whole-of-government value proposition

Mr Ong said Singapore is increasingly presenting a coordinated value proposition to biomedical companies. Regulatory processes are aligned with research, manufacturing and market access support from agencies such as A*STAR, the Economic Development Board and Enterprise Singapore. Within the Ministry of Health, closer alignment is also being explored between regulation, health technology assessment and clinical deployment.

This approach supports innovation in priority disease areas such as cardiovascular disease, diabetes and metabolic disorders, while reinforcing Singapore’s role as a credible reference market. Related national efforts to modernise healthcare delivery are also reflected in wider initiatives on digital transformation and workforce capability, as discussed in Singapore’s work on technology and training in healthcare.

Updating regulation for AI and emerging technologies

Rapid advances in AI, genomics and precision medicine are prompting changes to Singapore’s regulatory framework. HSA has launched updated AI in Healthcare Guidelines (AIHGle 2.0), building on the 2021 framework to address developments such as generative AI while maintaining safety, ethics and professional standards.

The updated guidelines introduce regulatory sandboxes that allow healthcare institutions to test low- to moderately low-risk AI tools in real-world settings. One example is an exemption sandbox for AI software used as a medical device within public healthcare institutions, recognising that such tools rely on high-quality, real-world clinical data.

These measures complement broader national ambitions to integrate AI into care delivery, outlined in Singapore’s strategy for an AI-enabled healthcare system, and emerging work in genomics and predictive medicine, including initiatives highlighted in Singapore’s genomic research programmes.

Balancing innovation, trust and public interest

Mr Ong concluded by framing health regulation as a bridge between scientific possibility and social acceptability. For Singapore, regulatory credibility, transparency and international cooperation are not only safeguards for patients but also economic assets that support innovation and global collaboration.

As healthcare technologies become more complex, HSA’s evolving role reflects Singapore’s wider ambition to act as a trusted connector in global healthcare, advancing innovation while maintaining high standards of safety and public confidence.