TO BE PUBLISHED November 2026
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This conference will examine next steps for UK medicines regulation and the future of regulatory innovation. As the MHRA considers responses to its consultation on a proposed Rare Disease Therapies Framework, the planned agenda will explore priorities for balancing innovation, patient access, safety, and international competitiveness within the UK regulatory system.
It will bring stakeholders and policymakers together to consider progress towards the aim of a more adaptive and proportionate approach to regulation in the context of rapidly evolving technologies and therapies. The proposed framework will be examined alongside implications of the new Investigational Marketing Authorisation pathway, including eligibility criteria and approaches to earlier patient access while maintaining confidence in safety standards. Discussion will also consider how clinical development, regulatory approval, reimbursement, and NHS adoption can be better aligned.
Clinical trials reform and evidence generation will also be focus, with discussion on implementation of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 and its implications for UK competitiveness and research capacity. Planned sessions will assess the role of adaptive and innovative trial designs in accelerating development timelines and supporting regulatory decision-making, including the use of real-world evidence, computational modelling, digital twins, and international safety data.
Attendees will also consider how the Health Data Research Service can strengthen the UK’s clinical research and pharmacovigilance capabilities, and the role it could play in mitigating long-term financial and regulatory risks for the NHS.
Further discussion will consider practical approaches to the regulation of personalised medicines, advanced therapies, and emerging technologies, including infrastructure requirements for scaling innovations such as point-of-care manufacturing, alongside priorities for reducing barriers to innovation adoption in the NHS. Surveillance and patient safety priorities will also be discussed, including public confidence, post‑market monitoring, the use of AI in pharmacovigilance and safer prescribing, and wider considerations for data governance and ethical oversight.
Overall areas for discussion include:
- regulatory policy and rare disease framework:
- the MHRA Rare Disease Therapies Framework - implications of the IMA pathway - developing eligibility criteria and evidential requirements
- alignment between clinical development, regulatory approval, patient access and reimbursement processes - enabling earlier access while maintaining confidence in safety standards
- clinical trials reform and development pathways:
- implementation of Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
- adaptive and innovative trial designs - real-world evidence, computational and in silico modelling, digital twins, and international safety data - development timelines and regulatory decision-making
- role of the Health Data Research Service in transforming UK clinical research and pharmacovigilance capabilities
- personalised medicine, innovation and NHS adoption:
- regulatory approaches for personalised medicines, gene and cell therapies, ATMPs and evolving technologies post-authorisation evidence generation
- post-authorisation evidence generation and frameworks for decentralised and point-of-care manufacturing - approaches to addressing barriers to NHS innovation adoption
- procurement, implementation pathways, and key themes from the House of Lords Science and Technology Committee inquiry into personalised medicine and AI
- feedback loops between research, industry, regulators and the NHS
- surveillance, safety and real-world evidence:
- patient engagement in regulatory decision-making - addressing misinformation and supporting public confidence
- pre-market evaluation and post-market surveillance for innovative technologies and medicines
- use of AI in pharmacovigilance and safer prescribing - forthcoming recommendations from the National Commission into the Regulation of AI in Healthcare
- collaboration and international partnerships:
- strengthening UK competitiveness through international regulatory cooperation
- UK-US co-operation on medical devices and AI - UK-Singapore regulatory innovation corridor
- international alignment and information-sharing to support innovation, safety and market access
