Morning, Thursday, 2nd October 2025
Online
This conference will examine priorities for medicine regulation in the UK.
Policy, regulation & funding
It will bring together stakeholders and policymakers to discuss the way forward following the UK’s Modern Industrial Strategy and what will be needed if its aims are to be achieved in reducing regulatory burdens and speeding up innovation. Delegates will also examine the forthcoming Life Sciences Sector Plan, and plans for a streamlined and flexible regulatory framework with accelerated medicine approval processes, support for innovative therapies and increased alignment with international standards.
Implications of key measures in the 10-Year Health Plan will also be examined, including speeding up UK clinical trials, and the move of the NHS from analogue to digital, and from a focus on sickness to prevention. Latest thinking on the plan’s announcement of a new regulatory framework for medical devices and a new joint process will also be considered, due to be launched by MHRA and NICE - which will aim to speed up decision-making - alongside key considerations in light of forthcoming changes which will give NICE power to remove outdated technologies and therapies from the NHS. We also expect discussion on the 2025 Spending Review, and options for targeting planned investment of up to £10bn in NHS technology and transformation, alongside £9.8bn for R&D for the DHSC.
New guidance, personalised therapies & delivery
It will be an opportunity to consider preparations for streamlining the transition to reformed clinical trial regulations coming into force in April 2026, so as to accelerate access to innovative treatments whilst maintaining patient safety. Sessions will examine proposed MHRA guidance to support regulation of new personalised cancer therapies, as well as next steps for expanding guidance to cover a wider range of highly personalised therapies, including for rare diseases.
Discussion will include priorities for preparing the NHS to deploy new personalised therapies, diagnostics, and supporting care pathways. Areas for discussion include issues around cost-effectiveness, clinical guideline development, and streamlined commissioning processes.
Following implementation of new post-market surveillance requirements for medical devices, delegates will assess priorities and practicalities for adopting a new comprehensive PMS system, plans to align safety measures with international best practice, and enhancing incident traceability.
Priorities for implementation of the updated integrated Innovative Licensing and Access Pathway will be discussed, and practical considerations for supporting rapid development of medicines through streamlining planning processes. Delegates will also assess ways forward for increasing early engagement opportunities for developers to ensure that medicines and technologies align with NHS needs.
In light of reports that all newborns in England will undergo whole genome sequencing within 10 years, delegates will look at ways in which the regulatory system could evolve to support a wider preventative agenda, including approaches to tackling additional regulatory challenges presented by earlier intervention, such as barriers to data collection.
Innovation, public trust & patient safety
Delegates will also assess priorities for emerging technologies, including ways forward for regulating AI-powered medical devices, as the MHRA pilot AI Airlock scheme is trialled, as well as for the Regulatory Innovation Office. Key considerations for the introduction of new innovator passports - which will allow new technology already assessed by one NHS organisation to be easily rolled out to others - will also be examined. Discussion will look at the role of collaborative partnerships in driving regulatory innovation, including next steps for the seven Centres of Excellence for Regulatory Science and Innovation.
The agenda will bring out latest thinking on patient safety and pharmacovigilance, including proposals for strengthened safety mechanisms, such as notification requirements for incidents, and preventative and corrective actions following initial UK approval. It will also be an opportunity to discuss best practice in using AI to ensure patient safety, accountability, and options for countering misinformation and improving public trust in medicine safety, particularly in a prevention-oriented health model.
We expect further discussion on options and practicalities for regulators to use environmental data in decision-making to support the move towards a net zero NHS. Delegates will also discuss options for international alignment in medicine regulation, as well as scope for effective cross-sector collaboration.
All delegates will be able to contribute to the output of the conference, which will be shared with parliamentary, ministerial, departmental and regulatory offices, and more widely. This includes the full proceedings and additional articles submitted by delegates. As well as key stakeholders, those due to attend include officials from DHSC; DoH, ROI; MHRA; GLD; UKHSA; HoC Library; and the Welsh Government.
