Regulatory Update

Singapore HSA–UK Fast Track Pathway 2025

The Singapore HSA–UK Fast Track Pathway 2025 introduces a Regulatory Innovation Corridor between Singapore’s HSA and the UK’s MHRA. The initiative allows companies to seek joint regulatory advice, accelerating access to breakthrough therapies in areas such as cancer, rare diseases, gene therapy, and digital health. The pathway improves regulatory efficiency while maintaining safety and strengthens both countries’ roles as global life sciences hubs.

Published on:
December 17, 2025

The Singapore HSA–UK Fast Track Pathway 2025 marks a major step in global regulatory collaboration, as Singapore’s Health Sciences Authority (HSA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launch a new Regulatory Innovation Corridor. The initiative aims to accelerate patient access to breakthrough health technologies while maintaining high safety and regulatory standards.

What Is the HSA–UK Regulatory Innovation Corridor?

The Regulatory Innovation Corridor is a coordinated fast track pathway that allows companies to engage both HSA and MHRA simultaneously. Under this framework, developers can seek joint regulatory advice early in development, helping them design stronger clinical trials, reduce duplication, and avoid unnecessary regulatory delays.

This first-of-its-kind collaboration supports faster, more predictable regulatory pathways for innovative health technologies intended for both the Singapore and UK markets.

Key Focus Areas and Technologies

The Singapore HSA–UK Fast Track Pathway 2025 targets high-impact therapeutic and technology areas, including:

  • Cancer and rare diseases
  • Dementia and obesity
  • Advanced diagnostics
  • Next-generation gene and cell therapies
  • Precision immunology
  • Digital health and AI-enabled medical technologies

The pathway is designed to support innovation without compromising patient safety or regulatory rigor.

Flagship Pioneering as the First Participant

Flagship Pioneering will be the first company to access the Regulatory Innovation Corridor. Its early-stage programmes span more than 40 companies, including Moderna, and cover emerging therapeutic modalities that may require new regulatory approaches.

This initial participation will help HSA and MHRA test and refine the framework before opening it to additional companies in future phases.

Strengthening UK–Singapore Regulatory Collaboration

The partnership builds on longstanding UK–Singapore cooperation in science, technology, and regulatory science. Through this initiative, both regulators will deepen collaboration in:

  • Early diagnosis and prevention
  • Healthy ageing strategies
  • Digital health and AI in healthcare
  • National initiatives such as Singapore’s Healthier SG and England’s 10-Year Health Plan

HSA and MHRA will also act as pioneer regulators in the HealthAI Global Regulatory Network, advancing global standards for AI in healthcare.

Impact on Industry and Market Access

For healthcare and life sciences companies, the Singapore HSA–UK Fast Track Pathway 2025 offers:

  • Earlier and aligned regulatory engagement
  • Reduced development timelines and duplication
  • Greater predictability for clinical and regulatory planning
  • Clearer routes to market for innovative therapies and technologies

The initiative strengthens Singapore’s position as a leading biotech and regulatory innovation hub, while supporting the UK’s life sciences growth strategy.

Next Steps for Developers

Companies developing breakthrough medicines, medical devices, and digital health solutions should monitor eligibility criteria and future phases of the corridor. Early engagement with regulators under this framework may significantly improve development efficiency and market readiness.

For the official announcement, refer to the Health Sciences Authority (HSA) press release, published on 12 December 2025.

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