SPEECH BY MR ONG YE KUNG, MINISTER FOR HEALTH AND COORDINATING MINISTER FOR SOCIAL POLICIES, AT THE HEALTH REGULATORY CONFERENCE, 12 OCTOBER 2026

Professor Benjamin Ong, Chairman of Health Sciences Authority (HSA)

Dr. Raymond Chua, CEO of HSA

Industry Partners

Guests

Ladies and Gentlemen

1.       We are here to talk about healthcare regulation. We know it is critical to building public trust and confidence in healthcare. It is always working quietly in the background, but it is an essential foundation to every good healthcare system.

Responding and Shaping a Changing Landscape

2.       Because patients seldom see it, we sometimes overlook how rapidly regulation needs to evolve. Technology, demographic shifts and medical advances continually reshape how care is delivered. So regulation must keep pace with these changes, and adapt intelligently to these new realities, at the same time, upholding standards, and that is the business of HSA.

3.       One major recent change, which was years in the making, was the enactment of the Healthcare Services Act (HCSA), and that was done in Singapore. Over the years, more healthcare services have moved into the community and the homes of patients, as ageing and co-morbidities shifted the centre of gravity of care beyond hospitals and clinics.

4.       And when that happened, HCSA responded to this shift by making regulation setting-neutral. In the past, we regulated services. That is a very traditional method. We regulated services based on the premises where those services are delivered, whether it is hospitals, clinics or nursing homes. Today, we regulate the service rather than the setting. This was a strategic shift to facilitate the emergence of new care models. So HCSA was an entire revamp of an existing regulatory regime.

5.       This is one example. Healthcare regulation must continue to evolve, and this year’s Conference reflects that imperative. For the first time, we are bringing together stakeholders from across the ecosystem, including healthcare providers, professionals, industry partners and regulatory experts.

6.       Healthcare regulation is therefore no longer about regulating just for safety. Increasingly, it shapes how the entire healthcare sector develops, from scientific discovery to patient access. Today, let me explain how the HSA’s regulatory approach is expanding across three boundaries, and how HSA is now ready to take these efforts further with our industry stakeholders.

Across Geographical Boundaries

7.       First, regulation is now cutting across geographical boundaries. We want our regulatory framework to be closely connected with those of our international partners, so that Singapore has a trusted reference agency which others can rely on.

8.       In 2022, HSA was the first national regulatory authority to attain the World Health Organization (WHO) Maturity Level 4 for medicines. In 2023, HSA was among the first three regulators recognised as a WHO Listed Authority for medicines regulatory systems. It attained WHO Stringent Regulatory Authority for high-risk in-vitro diagnostic medical devices that same year. This year, HSA became the first national regulatory authority to attain the highest WHO Maturity Level 4 for medical devices regulatory systems. This is a number of good accolades, thanks to HSA for working so hard.

9.       Today, jurisdictions such as Australia, Hong Kong, Malaysia, Brunei, the Philippines, South Africa, Sri Lanka, Switzerland, Thailand and the United Kingdom (UK) refer to HSA approvals to expedite their own regulatory processes for medical devices and pharmaceutical products. We ourselves have our own reference agencies that we also rely on.

10.      Singapore is also a member of the Access Consortium, alongside Australia, Canada, Switzerland and the UK. What we do through this Consortium is we align regulatory practices, share the work of evaluating therapeutic products and make better use of our scarce expertise. This reduces unnecessary duplication, accelerates access to safe and effective products, and benefits patients across all member countries.

11.      HSA’s next ambition is to work towards WHO Listed Authority status for vaccines. That is the mission I have given to HSA. This is critical to our pandemic prevention, preparedness and response efforts.

12.      As Artificial Intelligence (AI) is increasingly applied throughout the drug-development lifecycle, HSA is building its capabilities and developing regulatory guidance for its use. We want to ensure that innovation is not held back by regulatory uncertainty, and safety is not compromised in the pursuit of efficiency.

13.      In that vein, HSA is collaborating with the UK’s Medicines and Healthcare products Regulatory Agency. Together, the two authorities have established a Regulatory Innovation Corridor to speed up patient access to breakthrough therapies, including those that use AI for drug development and clinical trials. This provides innovators with a clearer, more predictable and coordinated pathway to engage with both regulators at the same time, to be able to plan ahead, design better trials, avoid duplication and avoid delays.

14.      Singapore, with all these efforts, is not simply a market of six million people. We can serve as a trusted gateway to markets encompassing hundreds of millions of people across other countries and regions.

Across the Healthcare Value Chain

15.      Second, HSA’s efforts will span the healthcare value chain. We will connect clinical development, regulation, health technology assessment and patient access.

16.      Today, companies have to engage multiple stakeholders as they move from research to clinical development, regulatory evaluation and patient access. I use the words “multiple stakeholders”, actually, it means multiple government agencies and departments. Each hand-off can add time, cost and uncertainty. We want to simplify and streamline this journey, without compromising the independence or rigour of each regulatory process.

17.      A first step is to make Singapore a more attractive place in which to conduct clinical trials. In July, Enterprise Singapore, the Economic Development Board (EDB), HSA and the Singapore Clinical Research Institute (SCRI) – which is a part of the Ministry of Health (MOH) family – began work on this effort.

18.      We are coordinating a common entry point for clinical research and regulatory engagement in Singapore, to be launched early next year. The intent is to ensure clinical trial sponsors receive earlier regulatory consultation, obtain clearer advice on clinical-development strategies and requirements, and support them in identifying investigators and coordinating trial sites.

19.      Under this common entry point initiative, we will halve approval timelines for selected lower-risk Phase Three clinical trials, from 30 days today to 15 days. We will also adopt one common template – this is an important point, because I think it is a pain point – to facilitate the consultation and approvals, including for trials conducted across different health clusters and different healthcare institutions. We are examining further improvements, including expediting the Institutional Review Board (IRB) approvals and reviewing the costs borne by trial sponsors. So, expect many changes. We are paying very close attention. I am personally paying close attention with some of the colleagues seated in front, and we are determined to make the change, and make Singapore much more competitive in clinical trials.

20.      Our ambition is for Singapore to become one of the region’s most efficient and trusted locations for clinical research and evidence generation. In so doing, we will deepen collaboration between industry, researchers and healthcare institutions.

21.      Further downstream, from November this year, HSA and the Agency for Care Effectiveness (ACE), will establish a Priority Track for Health Technology Assessment (HTA), for selected innovative health products.

22.      Regulatory and HTA decisions will remain independent, but they can be coordinated better. Under the Priority Track, HSA’s regulatory evaluation and ACE’s HTA can proceed concurrently rather than sequentially. For products submitted through ACE’s Company-Led Submission process, we intend to shorten the time to the first HTA decision from about one year currently to six to nine months after regulatory approval.

23.      We will share further details in the coming weeks and months.

Cross Regulatory Domains

24.      Finally, healthcare itself is becoming more integrated. The traditional boundaries between medicines, medical devices, services, professionals and health information are also blurring; many new models of care no longer fit neatly within a single regulatory domain.

25.      Take AI for example. An AI-driven medical device, an AI-enabled healthcare service and a clinician using AI may each be governed by different rules and regulations. These categories will probably have to remain, but there is value in one authority having oversight of AI applications that cut across them, from services to medical devices, to the professionals.

26.      The same is true of enforcement. Malpractice cases often involve the misuse of a health product and device, and misconduct by a professional at the same time. Fragmented regulation can miss these connections, while integrated oversight considers the whole picture.

27.      Hence, the third cross-boundary development is to bridge traditional regulatory domains and adopt an integrated and holistic approach to healthcare regulation.

28.      Today, these regulatory functions sit across three parts of Government. MOH regulates healthcare services, health information, human biomedical research and biosafety; HSA regulates health products; and the Secretariat of healthcare Professional Boards supports the regulation of healthcare professionals.

29.      We will bring these three regulatory domains together under HSA. This law was passed last month. For healthcare providers and industry, it means a clearer, simpler regulatory journey. For innovators, it means fewer disparate touchpoints and better-coordinated decisions. For patients, it means a system that can assess increasingly complex innovations safely and effectively.

30.      With this change, we aim to strengthen Singapore’s role as a thought leader in healthcare regulation.

Conclusion

31.      Good regulation must do two things at once: protect patient safety and at the same time enable useful innovation to scale across our healthcare system. These are not opposing objectives. When regulation is predictable, proportionate and trusted, good innovations flourish and reach patients sooner, and confidence in the system grows stronger.

32.      To support this, HSA will establish a Healthcare Industry Advisory Council in the first half of next year. The Council will bring together industry partners to identify emerging opportunities and risks, advise on capabilities needed across the health innovation ecosystem, and bring industry perspectives into policy development.

33.      These initiatives I just announced today reflect our commitment to building a regulatory system that is trusted, agile and forward-looking: one that holds firmly to safety and scientific rigour yet moves with innovation, rather than behind it. I invite all of you to join us in this endeavour. Thank you very much.