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Health Minister Ong Ye Kung said on March 10 that further innovations will help strengthen the medical workforce and bring new medicines to patients faster.
He said the Health Sciences Authority (HSA) became the first national regulator to achieve the World Health Organization’s (WHO) highest level of medical device regulation. This accreditation enables HSA to serve as a global standard for other regulatory authorities around the world.
Speaking at the opening ceremony of the International Medical Device Regulators Forum held at the NTUC Centre, Mr Ong said the Ministry of Health (MOH) and HSA have jointly developed and launched a revised Healthcare AI Framework to accommodate developments in artificial intelligence, including generative AI, to better support innovation while ensuring safety and quality.
The regulatory sandbox will facilitate the evaluation of AI solutions in real-world medical settings and ensure that AI tools are built using high-quality, real-world data, he added.
He also said that HSA has not yet received any registration applications for AI-developed medicines, but that it would welcome such applications in the near future.
AI is revolutionizing the drug development process, with simulated laboratory data replacing costly and time-consuming traditional early-stage clinical trials.
HSA “takes a technology-neutral approach to regulation and applies the same rigor to AI-developed medicines as traditional medicines,” Ong said.
This will enable Singapore to embrace innovation while being mindful of the risks as technology advances.
In his speech, Mr Ong said the HSA can also contribute to improving Singapore’s competitiveness in the biomedical industry by strengthening its position as a regional and global reference body.
In 2022, HSA received the highest rating from WHO for its medicines regulatory system, confirming that the system operates at a world-class level of sophistication.
Several other countries have also reached this so-called maturity level 4 for pharmaceuticals.
Ong said jurisdictions such as Australia, Hong Kong, Malaysia, the Philippines, South Africa, Sri Lanka, Switzerland, Thailand and the United Kingdom refer to HSA approvals when speeding up the regulatory process for medical devices and medicines.
Similarly, HSA also benchmarks its regulatory processes against those of other developed countries, such as the United States, the European Union, the United Kingdom, and Japan.
“Ultimately, health regulation will constitute a network of international cooperation, and Singapore will be one of its key nodes,” he added.
Singapore is also an AC member country.onsortium Approving new treatments to ensure rapid access to safe and effective medicines. Other members are Australia, Canada, Switzerland and the United Kingdom.
“All this has helped establish Singapore as a gateway for market access to hundreds of millions of people in many other countries and regions. Singapore is no longer just a market of six million people,” Mr Ong said.
Adjunct Professor Raymond Chua, HSA Chief Executive and MOH Deputy Director-General for Health, said the WHO’s achievements were driven by HSA’s essentially economic role in supporting the growth of Singapore’s biomedical sector.
To future-proof the health and medical technology sector, which is rapidly evolving with the development of AI, precision medicine and next-generation diagnostics, Singapore will integrate various institutional functions, including the HSA, to better support the growth of the biomedical industry, Mr Ong said.
Singapore will explore opportunities to align companies’ product offerings. the Priority disease areas such as cardiovascular disease, diabetes, and metabolic disorders.
With this approach, Ong said there is a need for a customized pathway that simultaneously facilitates regulatory approval, medical technology evaluation, clinical development and application.
“This will be a useful synergy within MOH. Although small, we at least believe that Singapore is a valuable commercial reference market. If the product is successful in Singapore, it will send a strong positive signal to the global market,” he said.
Historically, Singapore has been a dynamic trading hub connecting East and West. It later developed into a world financial center. As its economy matures, it is becoming a regional hub for manufacturing, shipping, aviation, and information and communications.unification, and professional service.
“In today’s world, Singapore offers more than just trade links for physical goods, services and investments,” Mr Ong said.
“We also serve as an interface for various standards and regulations around the world, where trust, integrity and reliability are common currencies.”
He added that HSA can play this role well and contribute to the advancement of global healthcare while keeping Singapore’s healthcare safe and effective.
