ABPI Regulatory Science symposium 2025

By Dan O’Connor, ABPI Director Regulatory and Early Access Policy

Last month, the ABPI was pleased to host our second Regulatory Science Symposium which brought together leaders from across the life sciences ecosystem to discuss how regulation can keep pace with innovation and help the UK remain globally competitive. Dan O’Connor, ABPI Director of Regulatory and Early Access Policy, reflects on the day.

Ambitions for future regulations

At the start of the day, we heard from Richard Torbett, ABPI Chief Executive, about the industry’s ambitions for the UK’s regulatory ecosystem. Richard spoke about how regulation can play a role in ensuring that the UK remains a competitive and attractive country for developing and launching new medicines.

Louise Knowles, Deputy Director, Innovation Accelerator and Regulatory Science, at the MHRA outlined the Agency’s work on its upcoming multi-year strategy, focused on being fast, expert and open. This means delivering more predictable and proportionate regulation; building deep expertise in areas that protect patient safety and drive innovation and strengthening international partnerships through initiatives such as the ACCESS Consortium, WHO and collaborations with the FDA and EMA.

Louise also shared the MHRA’s ambition to expand innovative pathways like the Innovative Licensing and Access Pathway (ILAP) and the Innovative Devices Access Pathway (IDAP), where the Agency can work more closely with HTA bodies like NICE, and create clearer gateways for emerging technologies.

UK strengths and areas to improve

The first panel explored the UK’s position in the global regulatory landscape. The panellists, Richard Tobett, Louise Knowles, Sunera Awan (Head Regulatory Affairs – UK, Ireland and Malta, Bayer), Ian Gray (Senior Director for Regulatory Affairs, Quality Commercial Operations and New Products UK/IE, Ipsen), and Joy Duffen (Trustee, Cure Parkinsons) highlighted the need for predictability in the regulatory system, and the advantages of alignment of MHRA requirements with HTA bodies and the NHS.

Participants agreed that, ultimately, patients really value timely and safe access to treatments.

The discussions also explored the important roles of charities and SMEs in driving innovation, and the need for clear, realistic regulatory ambitions; consistent delivery; and sustainable MHRA funding to maintain the UK’s competitive edge.

Cutting edge science and AI

Later presentations showcased cutting-edge work in regulatory science, including projects that apply evidence-based approaches and real-world data to improve the speed, safety and trustworthiness of data generation and the regulatory process. We also heard from Laura Cole, Policy Lead, at the Regulatory Innovation Office, which is working towards accelerating approvals, streamlining implementation, and scanning the horizon for emerging challenges from a government perspective.

The final panel turned to the question of how government, regulators, industry and patients can work together to enable responsible innovation:

• The government was seen to be important in setting the direction and providing targeted support to stimulate new approaches. 

• Regulators emphasised the importance of representative data and robust post-market surveillance, especially for AI and novel technologies. 

• Industry representatives highlighted the pace of technological change and the need for early and accessible engagement with regulators.

• Patient voices reminded the audience that risk tolerance and urgency can differ greatly, and so transparency and informed consent remain essential

The event closed with a shared sense of ambition and collaboration. There is clear momentum behind the MHRA’s new strategy, and a strong appetite across industry and partners to work together on new regulatory routes and pathways.

With initiatives such as the Regulatory Innovation Office and CERSI-AI, the UK has the tools and expertise to lead the next chapter in regulatory science, ensuring innovation reaches patients faster, safely and with public trust at its core.