Singapore: Health Sciences Authority’s partnership with overseas regulators and focus on AI in healthcare

In brief

Singapore’s Health Sciences Authority (HSA) has announced the launch of the new Regulatory Innovation Corridor with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). This new coordinated fast-track pathway will enable developers to engage both regulators early and concurrently, accelerating access to breakthrough health technologies in both jurisdictions.

The HSA highlighted that this initiative strengthens Singapore’s position as a leading biotech hub, accelerates access to innovative health technologies and sets the pace in global regulatory innovation. The HSA also drew attention to its recent partnership with A*STAR in establishing the Centre for Advancing Regulatory Science Research in Next-Generation Therapeutics (“ASCENT”). One of the ASCENT’s goals is to review the artificial intelligence (AI) in healthcare guidelines.


In more detail

Co-launched by the HSA and MHRA, the Regulatory Innovation Corridor will enable developers to seek joint advice from both regulators early and concurrently, helping developers to plan ahead and improve clinical trial designs, avoid duplication, and reduce delays. This is aimed at accelerating access to breakthrough health technologies in critical areas such as cancer, dementia, obesity, rare diseases and advanced diagnostics, without compromising on safety.

The new fast-track pathway is expected to strengthen Singapore and the UK’s positions as global healthcare hubs and boost each jurisdiction’s national healthcare strategy — the Healthier SG initiative and the 10-Year Health Plan, respectively.

AI in healthcare

The new partnership will be supported by Singapore and the UK’s joint work on AI in healthcare. Both the HSA and MHRA will serve as pioneer members of the HealthAI Global Regulatory Network, allowing both to contribute toward shaping the international rules for AI in healthcare.

This will also complement ongoing efforts by each regulator to foster innovation in health technologies. In Singapore, such initiatives include the establishment of the ASCENT and the review of the AI in Healthcare Guidelines published by the HSA, the Ministry of Health and Synapxe.

Other partnerships

The Regulatory Innovation Corridor is not the only partnership between the HSA and an overseas regulator on the horizon. Earlier this year, the HSA signed memorandums of undertaking with the following:

  1. The National Forensic Service of the Republic of Korea to collaborate in forensic science
  2. The Medical Device Authority of Malaysia to fast track medical device access
  3. The Department of Health of the Hong Kong Special Administrative Region to enhance cooperation in regulatory matters for health products

Key takeaways

The HSA has reiterated its commitment to Singapore’s position as a leading biotech hub, accelerating access to innovative health technologies and in particular, setting the pace in global regulatory innovation. Given the HSA’s increasing collaborations with other overseas regulators and focus on emerging industry trends (e.g., the use of AI in healthcare), companies should continue monitoring developments by the HSA, which may also have a knock-on effect on other overseas regulators.

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