Singapore working towards attaining top-level WHO recognition for vaccines: Ong Ye Kung

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 Monday (Oct 12).

The conference takes place just over a month after Parliament on Sept 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 United Kingdom'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.

新加坡在 2023 年成为首批获得世界卫生组织 (WHO) 药品监管体系认证的三个国家监管机构之一后，现在正努力争取在疫苗方面获得同样的地位。

“这对我们（新加坡）的疫情预防、准备和应对工作至关重要，”卫生部长王乙康在周一（10月12日）举行的首届卫生监管会议上表示。

本次会议召开于国会于 9 月 9 日通过《卫生科学局（修订）及其他事项法案》一个多月之后，该法案旨在巩固和建立卫生科学局 (HSA) 下的综合卫生监管职能。

该机构在法案通过后发表声明解释说：“一个综合监管机构将允许由一个机构管理许可申请和查询，使利益相关者能够更协调、更清晰地获取信息和答复。”

卫生部和卫生科学局表示，此次整合还有助于在研究和临床护理连续体中实现更好的监管协调，并补充说，研究人员和临床医生可以期待上游获得更清晰、更一致的指导。

卫生部和卫生科学局补充说，这反过来加强了对研究参与者的保护，同时为从研究到最终临床应用提供了更清晰的途径。

王乙康在讲话中指出，人工智能（AI）正越来越多地应用于药物研发的整个生命周期中。王乙康同时也是社会政策统筹部长。

“新加坡卫生科学局正在提升自身能力，并制定相关监管指导方针。我们希望确保创新不会因监管的不确定性而受阻，同时在追求效率的过程中不会牺牲安全性。”他说道。

该机构还在监管创新走廊方面与英国药品和保健产品监管机构开展合作。

根据这项计划，患者获得突破性疗法（包括利用人工智能进行药物开发和临床试验的疗法）的速度可以加快。

卫生部长表示，这将为创新者提供一条“更清晰、更可预测和更协调的途径”，让他们能够同时与两个监管机构进行沟通，从而能够提前规划、设计更好的试验、避免重复工作和避免延误。

“新加坡不仅仅是一个拥有六百万人口的市场。我们可以成为通往其他国家和地区数亿人口市场的可靠门户，”他补充道。

值得信赖的临床研究和证据生成平台

Ong表示，为此，HSA的努力将涵盖整个医疗保健价值链。

我们将把临床开发、监管、卫生技术评估和患者准入联系起来。

Ong指出，在当今环境下，企业从研究到临床开发、监管评估和患者准入，都需要与多个利益相关者进行沟通。

部长指出，每一次交接都会增加时间、成本和不确定性，并补充说，新加坡打算简化和精简这一流程，同时又不损害每个监管流程的独立性或严谨性。

他表示，这将需要使新加坡成为开展临床试验更具吸引力的地点。

Ong 指出，新加坡经济发展局、卫生科学局和新加坡临床研究所于 7 月开始共同努力，协调新加坡的临床研究和监管参与的共同入口。

他表示，该计划预计将于明年初启动。

卫生部长补充说，此举旨在确保临床试验申办者能够更早地获得监管咨询，获得更清晰的临床开发策略和要求方面的建议，并支持他们确定研究人员和协调试验地点。

根据这项计划，部分低风险三期临床试验的审批时间预计将从 30 天缩短至 15 天。

在简化流程方面，该计划还将采用一个通用模板，以方便咨询和审批，包括在多个医疗机构进行的试验。

“我们的目标是使新加坡成为本地区最高效、最值得信赖的临床研究和证据生成中心之一。为此，我们将深化产业界、研究人员和医疗机构之间的合作，”王先生补充道。