October 2025
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This conference examined priorities for medicine regulation in the UK.
Policy, regulation & funding
It brought together stakeholders and policymakers to discuss the way forward following the UK’s Modern Industrial Strategy and what will be needed to reduce regulatory burdens and speed up innovation. Delegates examined the recently published Life Sciences Sector Plan, including next steps for streamlining and flexibility in the regulatory framework with accelerated medicine approval processes, supporting innovative therapies and increasing alignment with international standards, as well as improving adoption and procurement.
The proposed development of a new Health Data Research Service was discussed - which will encompass population genomic, diagnostic, and clinical data - including practicalities for using the service to attract global clinical trials and investment, while maintaining robust privacy and cybersecurity methods. There was also discussion on ways forward for the service to support real-world evidence generation and aid regulators with better-informed decision-making.
Implications of key measures in the 10-Year Health Plan were also 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 was also considered - due to be launched by the Medicines and Healthcare products Regulatory Agency and National Institute for Health and Care Excellence, which will aim to speed up decision-making - alongside key considerations in light of forthcoming changes which will give the National Institute for Health and Care Excellence power to remove outdated technologies and therapies from the NHS. We also expected 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 research and development for the Department of Health and Social Care.
New guidance, personalised therapies & delivery
It was 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 examined proposed Medicines and Healthcare products Regulatory Agency 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 included priorities for preparing the NHS to deploy new personalised therapies, diagnostics, and supporting care pathways. Areas for discussion included issues around cost-effectiveness, clinical guideline development, and streamlined commissioning processes.
Following implementation of new post-market surveillance requirements for medical devices, delegates assessed priorities and practicalities for adopting a new comprehensive post-market surveillance 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 were discussed, and practical considerations for supporting rapid development of medicines through streamlining planning processes. Delegates also assessed ways forward for increasing early engagement opportunities for developers to ensure that medicines and technologies align with NHS needs, as well as priorities for supporting developers to bring products to market in the UK as some pharmaceutical companies have recently removed planned investment in the UK.
In light of reports that all newborns in England will undergo whole genome sequencing within 10 years, delegates looked 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 also assessed priorities for emerging technologies, including ways forward for regulating artificial intelligence-powered medical devices, as the Medicines and Healthcare products Regulatory Agency’s pilot artificial intelligence Airlock scheme is trialled, as well as for the Regulatory Innovation Office. Key considerations for the introduction of new innovator passports, which allows new technology already assessed by one NHS organisation to be easily rolled out to others, were also examined, alongside the new rules-based pathway for MedTech, aiming to expand the National Institute for Health and Care Excellence’s technology appraisal process to cover certain devices, diagnostics and digital products. Sessions looked at priorities for collaborative partnerships in driving regulatory innovation, including next steps for the seven Centres of Excellence for Regulatory Science and Innovation, as well as the future for strategic government partnerships as the new Moderna Innovation and Technology Centre opens for work on new mRNA vaccines.
The agenda brought 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 was also an opportunity to discuss best practice in using artificial intelligence 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 expected 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 discussed options for international alignment in medicine regulation, following the Medicine and Healthcare products Regulatory Agency’s designation as a World Healthcare Organisation-Listed Authority, as well as scope for effective cross-sector collaboration.
All delegates were 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 who attended include parliamentary pass-holders from both Houses of Parliament and officials from the Department of Health and Social Care; Department for Business and Trade; Department of Health, ROI; Medicines and Healthcare products Regulatory Agency; Government Legal Department; UK Health Security Agency; Office for Life Sciences; House of Commons Library; the Welsh Government; and The Scottish Government.
