OCTOBER 12 — After becoming among the first three national regulatory authorities to attain the World Health Organisation’s (WHO) classification as a listed authority for medicines regulatory systems in 2023, Singapore is now working towards attaining the same status for vaccines.

“This is critical for our (Singapore) pandemic prevention, preparedness and response efforts,” said Minister for Health Ong Ye Kung at the inaugural health regulatory conference on today.

The conference takes place just over a month after Parliament on September 9 passed the Health Sciences Authority (Amendment) and Other Matters Bill, to consolidate and establish an integrated health regulatory function under the Health Sciences Authority (HSA).

“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,” the authority explained in a statement after the Bill was passed.

The consolidation also allows greater regulatory alignment across the research and clinical care continuum, MOH and HSA stated, adding that researchers and clinicians can expect clearer and more consistent guidance upstream.

This, in turn, strengthens protection for research participants while providing a clearer pathway from research to eventual clinical application, MOH and HSA added.

In his speech, Ong, who is also Coordinating Minister for Social Policies, noted that artificial intelligence (AI) is increasingly applied through 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,” he said.

The authority is also collaborating with the UK’s Medicines and Healthcare products regulatory agency on the regulatory innovation corridor.

Under the initiative, patient access to breakthrough therapies, including those that use AI for drug development and clinical trials, can be sped up.

This will provide 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, the health minister said.

“Singapore 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,” he added.

Trusted place for clinical research, evidence generation

To this end, HSA’s efforts will span the healthcare value chain, Ong said.

“We will connect clinical development, regulation, health technology assessment and patient access.”

Ong noted that in today’s context, companies have to engage multiple stakeholders as they move from research to clinical development, regulatory evaluation and patient access.

Each hand-off can add time, cost and uncertainty, the minister noted, adding that Singapore intends to simplify and streamline this journey, without compromising the independence or rigour of each regulatory process.

This, he said, would entail making Singapore a more attractive place in which to conduct clinical trials.

Ong pointed to the joint effort between the Singapore Economic Development Board, HSA and the Singapore Clinical Research Institute, which in July began work to coordinate a common entry point for clinical research and regulatory engagement here.

The initiative is expected to be launched early next year, he said.

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, the health minister added.

Under the initiative, approval timelines for selected lower-risk phase three clinical trials are expected to be cut from 30 days to 15 days.

In terms of streamlining processes, the initiative will also adopt one common template to facilitate the consultation and approvals, including for trials conducted across several healthcare institutions.

“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,” Ong added. — AsiaOne