Morning, Thursday, 2nd October 2025
Online
This conference will examine priorities for medicine regulation in the UK.
It will bring together stakeholders and policymakers to discuss ways forward following the launch of the new integrated Innovative Licensing and Access Pathway, and what is needed if its aims are to be achieved in supporting rapid development of medicines through streamlining planning processes. Attendees will also assess next steps following the publication of the updated Medical Devices Regulatory Reform roadmap.
Ahead of the 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.
Sessions will examine the proposed MHRA guidance to support the regulation of new personalised cancer therapies, to streamline access while prioritising safety and efficacy, as well as next steps for expanding guidance to cover a wider range of highly personalised therapies, including rare diseases.
Options for accelerated approval pathways, conditional marketing authorisations, and adaptive clinical trials tailored to emerging technologies, will also be examined, including ways forward for regulating AI-powered medical devices, as the MHRA pilot AI Airlock scheme is trialled. 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.
We also expect the agenda to bring out latest thinking on patient safety and pharmacovigilance, including proposals for strengthened safety mechanisms, including notification requirements for incidents, and preventive and corrective actions taking place after a device is first approved for the British market. It will also be an opportunity to discuss the role of AI in safety mechanisms, accountability for patient feedback, and next steps for countering misinformation and ensuring public trust in medicine safety, particularly in a prevention-oriented health model.
Additional discussion is expected on options and practicalities for regulators to use environmental data in decision-making, to support the move toward a net zero NHS. Strategic next steps for international regulatory alignment in medicine regulation will also be considered, as well as the scope for more effective regulation via cross-sector collaboration.
With the agenda currently in the drafting stage, overall areas for discussion include:
- regulatory reform:
- streamlining rollout of Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
- implementation of the Medical Devices (Post-market Surveillance Requirements) Regulations - priorities for delivering a risk-based, proportionate regulatory approach
- addressing concerns about transparency and public trust - alignment with international standards
- innovative licensing and access:
- progress and next steps for the ILAP framework across regulatory and clinical systems - co-ordination across MHRA, NICE, and NHS partners
- system readiness within the NHS - implications for patients and developers
- advanced therapies and personalisation:
- MHRA guidance on personalised cancer treatments - potential extension of guidance to therapies for rare diseases
- priorities for developing bespoke regulatory pathways for gene and cell therapies - ensuring consistent safety and efficacy standards
- post-market surveillance and safety:
- PMS system rollout under new regulations - improving reporting and traceability, and early detection of safety issues
- priorities for the use of patient feedback within safety monitoring - balancing real-time surveillance with practicalities for manufacturers
- AI and emerging technologies:
- evaluating outcomes from the MHRA’s AI Airlock sandbox - approaches to generating the evidence needed to demonstrate safety and effectiveness of AI-powered devices for approval
- ensuring patient safety while progressing innovation - adapting regulatory frameworks to remain clear and workable as technologies develop and become more complex
- pharmacovigilance and patient trust:
- advancing engagement with patients on regulatory decisions - strategies for transparent communication and managing concerns around adverse effects
- addressing misinformation around medicines while supporting public understanding and confidence in safety systems
- collaboration:
- frameworks for cross-sector networks to enable regulatory innovation - what can be learned from the Centres of Excellence for Regulatory Science and Innovation
- opportunities for knowledge sharing to inform policy development - coordination between regulators, HTA bodies, and system leaders
- innovation in environmental stewardship:
- managing potential impact of new technologies on NHS environmental goals
- opportunities for the use of environmental data in regulatory and procurement decisions - developing approaches to assess sustainability in technology appraisals
- international priorities:
- considerations and options for regulatory alignment with other jurisdictions - addressing barriers to reciprocal recognition of standards
- maintaining UK competitiveness alongside safeguarding and quality - strategic opportunities for advancing international market access for UK innovations
- an innovation-friendly system:
- options for reducing uncertainty and regulatory burden for developers - strategies to improve clarity across new and existing frameworks
- developing capability across regulatory bodies to anticipate change - promoting the UK as a destination for health tech development and clinical research
