Singapore healthcare regulation speeds up innovation

SINGAPORE – Patients in Singapore will have earlier access to innovative health products and devices, under various initiatives announced on Oct 12 by Health Minister Ong Ye Kung.

Come early 2027, one of these initiatives will provide more support for clinical trial sponsors, including earlier consultations on regulatory matters, getting clearer advice on the relevant requirements, and support in identifying investigators and coordinating trial sites.

Approval timelines for certain lower-risk clinical trials that have reached phase three could be halved from the current 30 days to only 15 days, said Ong.

Phase three clinical trials are typically the last stage of testing before a drug’s details and clinical trial results are submitted to the regulatory authorities for approval.

Good healthcare regulation brings about predictability and trust, said Ong at the opening ceremony of the inaugural Health Regulatory Conference.

In his speech, he announced various initiatives that the Health Sciences Authority (HSA) was involved in, which could help bring innovative products to the Singapore market faster.

He also said that one common template will be adopted for the purpose of regulatory consultation and approvals, including for clinical trials done across several healthcare institutions, which he said was a pain point to carrying out clinical trials currently.

“So, expect many changes. We are paying very close attention… We are determined to make the change, and make Singapore much more competitive in clinical trials,” Ong added.

The Ministry of Health (MOH) is also likely to reach its funding decisions more quickly, such as whether subsidies should be provided for selected innovative health products.

This comes with the establishment of a priority track for health technology assessment (HTA) from November, by HSA and MOH’s Agency for Care Effectiveness (ACE).

For selected innovative health products, ACE can conduct its HTA concurrently when HSA is carrying out its regulatory evaluation, instead of proceeding only after HSA has concluded its evaluation.

With this process in place, Ong said the authorities intend to shorten the time needed to reach the first HTA decision.

It will likely take six to nine months post-regulatory approval, down from the current one year post-approval.

HTA refers to the established scientific research methodology that ACE uses to look into the benefits and costs involved for certain drugs, or medical devices, diagnostics or medical services.

The HTA results are used to support recommendations on whether subsidies should be provided for the drugs or medical technologies.

Singapore a trusted gateway

With HSA serving as an important reference agency for other international partners, it helps cement Singapore’s position as a “trusted gateway to markets encompassing hundreds of millions of people across other countries and regions”, said Ong, who is also Coordinating Minister for Social Policies.

He noted that HSA has worked hard and achieved various accolades, including becoming the first national authority assessed by the World Health Organization (WHO) at maturity Level 4 for medical device regulation, and a WHO-listed authority for medicines.

“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,” said Ong.

Other efforts by HSA included building its capabilities and developing regulatory guidance for the use of artificial intelligence across the healthcare sector throughout the drug-development life cycle.

Currently, Ong noted, an AI-driven medical device, an AI-enabled healthcare service and a clinician using AI may each be governed by different rules and legislation.

This will change with the upcoming consolidation of regulatory powers under HSA’s wings, after the passing of the Health Sciences Authority (Amendment) and Other Matters Bill in Parliament on Sept 9.

With the consolidation of powers within Singapore’s integrated health regulator, it allows for timely access to beneficial healthcare innovations, and greater convenience and clarity for the healthcare industry and professionals.

HSA’s future planning will benefit from an Industry Advisory Council that will also be established in the first half of 2027 and brings together partners with industry experience.

According to HSA, the council will identify emerging opportunities and risks, advise the regulator on future capability needs, and bring industry perspectives into policy development.

Ong said that the initiatives announced at the conference reflect Singapore’s 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”.

He described regulation as an essential foundation of every healthcare system, and critical to building public trust and confidence in healthcare.

“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.

“When regulation is predictable, proportionate and trusted, good innovations flourish and reach patients sooner, and the confidence in the system grows stronger,” Ong said.

The three-day Health Regulatory Conference, jointly organised by MOH and HSA, is expected to draw more than 900 healthcare professionals, industry representatives and academics from Singapore and overseas to discuss issues related to healthcare regulation.

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