[SINGAPORE] The Health Sciences Authority (HSA) is aiming to strengthen Singapore’s competitiveness in the biomedical industry, especially in the area of health regulation.

Its expanded economic role will comprise three key thrusts, said Minister for Health and Coordinating Minister for Social Policies Ong Ye Kung on Tuesday (Mar 10).

He was speaking at the opening ceremony of the International Medical Device Regulators Forum’s 29th session, which is being held from Mar 9 to 13.

One of them will be to collaborate to “put forward a holistic value proposition to the biomedical sector”.

This includes bringing together:

The Agency for Science, Technology and Research, to anchor translational research and industry innovation;
• The Economic Development Board, to facilitate manufacturing investment; and
• HSA, to provide a rigorous and efficient regulatory process.

Enterprise Singapore will also help local companies expand into regional and international markets, supported by regulatory and capability guidance from HSA.

International biomedical companies establishing a presence in Singapore, meanwhile, can “look forward to HSA’s rigorous yet expedient registration process”, the authority said.

HSA added that these moves “will contribute to Singapore’s biopharmaceutical manufacturing output”, which it noted has “doubled over the past two decades to S$13.9 billion in 2023”.

The push also complements the Research, Innovation and Enterprise plan announced by the National Research Foundation in 2025. Under the plan, S$37 billion will be invested over five years, with human health and potential identified as one of its key domains.

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A strong international reference authority

HSA is also seeking to strengthen its position as a regional and global reference authority.

It achieved the highest World Health Organization’s (WHO) Maturity Level 4 status for medical device regulation this year, becoming the first national regulatory authority worldwide to reach this milestone. 

In 2022, it attained WHO’s highest maturity level for medicines and imported vaccines regulation. It was also among the first three regulators designated as a WHO-Listed Authority.

HSA said such achievements mean it is “recognised globally as operating at an advanced level of regulatory performance, ensuring that medicines in Singapore meet high safety, efficacy and quality standards”.

Dr Raymond Chua, chief executive of HSA, said that these milestones reflect the authority’s “sustained effort to build a robust and forward-looking regulatory system that safeguards patients, while enabling timely access to innovative health products”.

He noted that HSA will continue to collaborate with regulators to establish itself “as a global reference point that they can confidently rely on for the evaluation of their products”.

Evolving regulatory framework

As technology advances, HSA is updating its regulatory framework with new guidelines governing the use of artificial intelligence (AI) in healthcare.

The updated Artificial Intelligence in Healthcare Guidelines were also announced on Tuesday.

The framework, co-developed by the Ministry of Health (MOH) and HSA, is an updated version of the 2021 guidelines. Ong said it aims to address “developments in AI, such as generative AI, to better support innovation while ensuring safety and quality, preserving (the) ethics and values of the healthcare profession”.

The updated guidelines will enable healthcare institutions to build and implement clinically safe and effective AI solutions, while facilitating the evaluation of these technologies in real-world healthcare settings.

For instance, the AI-Software as a Medical Device Exemption Sandbox allows institutions to deploy low to moderately low-risk AI-driven medical devices for in-house use without typical licensing and registration requirements. 

“Regulation mediates between what is scientifically and clinically possible, and what is socially and publicly acceptable,” Ong added. “It means constantly evolving our regulatory regime, so that we can embrace innovation, while taking care of the risks.”

Against this backdrop, AI will also be used to develop new drugs, replacing “costly and time-consuming early-phase clinical trials with laboratory-generated simulated data”.

HSA will accept such applications for registration, although it has yet to receive one.

Ong said the authority will “take a technology-neutral approach to regulating, applying the same rigour to AI-developed drugs as it does to conventional drugs”.

MOH said the framework will be periodically updated to keep pace with technological developments.

These initiatives align with Singapore’s plans for AI-led transformation across four sectors, including healthcare, announced by Prime Minister Lawrence Wong during his Budget speech on Feb 12.

The new National AI Council, chaired by PM Wong, will monitor and develop these AI-led initiatives.

Established in 2001, HSA is a statutory board under MOH that regulates health products, manages Singapore’s national blood bank, and provides forensic and analytical services.

This year, Singapore is hosting the International Medical Device Regulators Forum, which promotes collaboration and knowledge exchange among global medical device regulators. Twelve jurisdictions, including Singapore, are represented on the forum’s management committee.