Jackson conveyed that the MHRA is positioning itself as a proactive and collaborative regulator, aiming to support innovation across fields such as artificial intelligence (AI), decentralized manufacturing, and clinical trials. He stressed the agency’s dedication to maintaining alignment with international standards while accelerating access to safe and effective healthcare products in the UK. Initiatives like the Innovation Office and the Innovative Licensing and Access Pathway (ILAP) were highlighted as key tools in this mission. He emphasized that MHRA is embracing a new era of innovation while staying true to its core mission: ensuring the safety and efficacy of medicines and healthcare products for patients.
A Regulator with an Enabling Mindset
Jackson described the MHRA’s transformation into an “enabling regulator”—one that actively supports innovation without compromising on safety. He underscored the importance of collaboration with stakeholders, including industry leaders and other regulatory bodies.
This approach is particularly relevant in the medical device sector, where much of today’s innovation is taking place.
AI and the Future of Regulation
AI is a key area of focus for the MHRA. Following a UK government white paper, the agency released its own guidance on AI in healthcare. Jackson explained that much of the current AI innovation is centered on medical devices. To support this, the MHRA has introduced an “airlock” pilot phase, designed to facilitate mutual learning between regulators and innovators in a controlled environment.
Building Infrastructure for Innovation
The UK has also launched the Centre for Regulatory Science and Innovation (CeRSI), which now leads seven formal workstreams. Jackson pointed out that innovation is not limited to products, it also extends to regulatory practices. The MHRA is exploring how AI can be used to expedite regulatory processes and how to best leverage available data. These initiatives aim to modernize both the development and oversight of healthcare technologies.
Clinical Trials and Legislative Updates
The MHRA is actively updating its clinical trials regulations to streamline processes and improve collaboration. Jackson noted that this work is already underway, with new guidance being developed to make regulatory processes more efficient.
Global Collaboration
The MHRA is also part of the Access Consortium, a partnership with regulators in Australia, Canada, Switzerland, and Singapore. He emphasized that the MHRA does not operate in isolation but works closely with international partners to bring medicines to patients more efficiently. “We don’t do this alone,” he said. “We’re working with like-minded regulators to bring medicines to patients smarter and faster.”
Conclusion
The MHRA’s evolving role signals a broader transformation in regulatory philosophy—from a traditional oversight model to one rooted in partnership and innovation. By modernizing its approach and fostering collaboration, the UK is paving the way for a more agile and responsive regulatory environment. Jackson expressed confidence that these efforts will position the MHRA to effectively support industry innovation in the years ahead.
Disclaimer
This is an informal summary of presentations made on 12 and 14 May 2025 at the 2025 ISPE Europe Annual Conference in London. It has not been vetted by any of the agencies or regulators mentioned in this article, nor should it be considered the official positions of any of the agencies mentioned.
