TO BE PUBLISHED November 2026
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This conference will examine next steps for medicines regulation in the UK and the future for regulatory innovation. It will consider how the regulatory system should develop as reforms across medicines regulation and clinical research move forward, and in response to emerging technologies, new treatment approaches and changing expectations around evidence generation.
The agenda will explore pathways to unlocking earlier access to promising treatments, rare disease innovation, clinical trials reform, personalised medicines and advanced therapies, surveillance and pharmacovigilance, and international collaboration and competitiveness.
It will bring together stakeholders and policymakers as the Medicines and Healthcare products Regulatory Agency considers responses to its proposed Rare Disease Therapies Framework and with wider reform underway across medicines regulation and clinical research. In this context, delegates will discuss priorities for balancing innovation, patient access, safety and international competitiveness within the UK regulatory system, including options for regulatory pathways, evidence requirements and coordination with the NHS that can effectively contribute to delivery of the Life Sciences Sector Plan and its one-year-on priorities around research, innovation, investment and adoption.
Regulatory pathways, earlier access & patient safety
Sessions will assess how the UK medicines regulatory framework can support earlier access to promising treatments while maintaining confidence in standards for safety, quality and effectiveness - including workable arrangements for patients, clinicians and developers where evidence remains uncertain.
Areas for discussion include:
- rare diseases: the MHRA Rare Disease Therapies Framework - new approaches such as the Investigational Marketing Authorisation pathway - eligibility criteria and evidential requirements
- earlier access: accelerated approval and conditional authorisations - ongoing evidence generation and long-term monitoring of outcomes
- decision-making processes: considerations for managing uncertainty - accounting for patient needs and views on acceptable uncertainty, consent and conditions attached to earlier access
- coordination:
- approaches to better aligning regulatory approval, health technology assessment, reimbursement decisions and NHS adoption
- addressing differences in evidence requirements and barriers to uptake
Clinical trials reform, evidence generation & research infrastructure
Delegates will examine early implementation of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 and implications for the UK’s clinical research environment.
Areas for discussion include:
- trial delivery: developing adaptive and innovative trial designs - improving efficiency and quality monitoring - reducing barriers to participation - site capacity and recruitment
- evidence generation: new approaches and use of real-world evidence - computational and in silico modelling - digital twins - international safety data - enabling informed regulatory decision-making
- infrastructure: requirements for scaling innovative approaches - strengthening research capability and medicines safety monitoring - initiatives such as the Health Data Research Service - improving pharmacovigilance
Advanced therapies, personalised medicines & emerging technologies
Further sessions will consider practical issues in regulating personalised medicines, gene and cell therapies, Advanced Therapy Medicinal Products and other emerging technologies.
Areas for discussion include:
- manufacturing models:
- challenges associated with decentralised and point-of-care production - maintaining quality and consistency across sites
- wider considerations around supply chains - workforce capability - NHS readiness
- adoption: reducing barriers for transitioning research to approval, implementation and routine care - procurement pathways - clinical and financial oversight
- sector feedback: post-authorisation evidence generation - the House of Lords Science and Technology Committee inquiry into personalised medicine and AI - feedback loops between research, industry, regulators and the NHS
Surveillance, pharmacovigilance & the future regulatory landscape
The agenda will also draw on latest thinking for maintaining effective safety monitoring in an increasingly complex medicines landscape.
Areas for discussion include:
- monitoring: pre-authorisation assessment and post-authorisation surveillance - utilising emerging technologies and data sources for identifying safety signals
- artificial intelligence use in pharmacovigilance: potential for safety monitoring and safer prescribing - implications of emerging recommendations from the National Commission into the Regulation of AI in Healthcare
- maintaining trust and transparency: data governance and ethical oversight - patient engagement in regulatory decision-making - addressing misinformation and supporting public confidence
International alignment & regulatory competitiveness
Further discussion will consider the role of international regulatory cooperation in supporting research, innovation and timely access to new treatments.
Areas for discussion include:
- international coordination: balancing global alignment with appropriate national oversight - strengthening joint working on emerging technologies, advanced therapies and monitoring
- competitiveness:
- levers to drive the UK’s attractiveness for commercial and academic research investment - alignment with the Life Sciences Sector Plan to support investment, innovation and growth
- the relationship between regulatory innovation, market access and research delivery
- partnerships: implications for medicines regulation of UK-US cooperation on medical devices and AI - the UK-Singapore regulatory innovation corridor - information-sharing
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. This includes the full proceedings and additional articles submitted by delegates. As well as key stakeholders, those already due to attend include officials from the Department of Health and Social Care; House of Commons Library; Medicines and Healthcare products Regulatory Agency; Office for Investment; and The Scottish Government.
