MHRA Call for Evidence: Beyond ADMET: AI for Medicines Safety
Updated: Oct 12
On 22 September 2026, the Medicines and Healthcare products Regulatory Agency (MHRA), together with the Regulatory Innovation Office (RIO), opened a call for evidence on the use and development of artificial intelligence (AI)-based approaches for medicines safety evaluation. The survey seeks information on current and planned uses of AI, as well as barriers and challenges relating to model development, validation, data access, data sharing and regulatory considerations. The findings will inform the development of the MHRA’s planned Beyond ADMET: AI for Medicines Safety regulatory sandbox and future regulatory work in this area.
Overview
Authority | Medicines and Healthcare products Regulatory Agency (MHRA) and Regulatory Innovation Office (RIO) |
Date | 22 September 2026 |
Focus | Use and development of AI-based approaches for medicines safety, including model validation, data access, data sharing and regulatory considerations. |
Type | Open call for evidence and stakeholder survey |
Deadline for comments | 22 December 2026 |
What is this about?
The MHRA is exploring how AI-based tools could support medicines safety evaluation, particularly in relation to absorption, distribution, metabolism, excretion and toxicity (ADMET).
Such approaches may combine traditional preclinical data with clinical and real-world data to model biological and clinical interactions and improve understanding of how medicines behave across different populations, disease states and clinical conditions. The MHRA notes that AI-based approaches could also support investigation of adverse drug reactions and longer-term or otherwise difficult-to-observe outcomes.
At the same time, the MHRA considers AI-based ADMET tools to be at an early stage of regulatory readiness. Areas of uncertainty include model performance, evidential requirements, data quality and accessibility, as well as the role of cross-sector data sharing in supporting model development and validation.
The planned Beyond ADMET: AI for Medicines Safety regulatory sandbox is intended to provide a structured environment in which developers can test, demonstrate and refine AI-based predictive tools intended for use in drug development and regulatory submissions. The sandbox is also intended to help build foundational knowledge, identify evidence gaps and potential regulatory needs, and support discussion of evidence requirements and regulatory expectations for AI methods in medicines safety-related decision-making.
Survey details
The MHRA is seeking perspectives and practical experience from organisations involved across the medicines development pathway, including toxicology, preclinical and clinical research and testing, life sciences, biotechnology and AI.
Respondents are encouraged to provide examples of current practice, challenges and priorities. Organisations do not need to be currently using AI-based approaches for medicines safety to participate; the MHRA is also interested in future plans and areas of unmet need.
The call for evidence covers areas including:
Current, developing or planned uses of AI-based approaches for medicines safety evaluation
Model development and validation
Data availability, accessibility and quality
Data sharing
Regulatory considerations
Current challenges, priorities and areas of unmet need
Useful links
Access the official materials and submit your comments.
Announcement and overview
Go to the official comment submission page
Key timeline
Publication: 22 September 2026
Deadline for comments: 22 December 2026.
The MHRA website refers both to 5:00 pm and 11:59 pm (UK time). Respondents may wish to submit well before the deadline to avoid uncertainty.
Why this matters
The call for evidence provides stakeholders with an opportunity to inform the MHRA’s understanding of the current technological capabilities, data requirements and regulatory considerations associated with AI-based approaches to medicines safety.
For organisations developing or applying AI-based predictive tools, issues such as model validation, evidential requirements, data quality and accessibility may become important considerations as the MHRA explores the potential regulatory use of these approaches.
Providing input at this stage may help stakeholders highlight practical challenges, evidence gaps and areas of regulatory uncertainty as the MHRA develops its regulatory sandbox and considers future regulatory work in this area.
Who should consider responding?
Pharmaceutical and biotechnology companies developing or using AI-based approaches in medicines development
Developers of AI-based tools for medicines safety evaluation
Organisations involved in toxicology and preclinical research and testing
Clinical research organisations and other organisations involved in clinical medicines development
Researchers and data organisations working with relevant preclinical, clinical or real-world data
Practical implications
Stakeholders should consider:
Reviewing current or planned uses of AI-based approaches in medicines safety evaluation
Identifying challenges relating to model development, validation and evidential requirements
Assessing issues relating to data availability, quality, accessibility and sharing
Identifying areas of unmet need or regulatory uncertainty that could be supported by practical examples
Assessing opportunities to contribute relevant experience to the development of the MHRA regulatory sandbox
Assessing whether existing validation, data governance and evidence-generation approaches for AI-based medicines safety tools would support future regulatory acceptance
Support with stakeholder responses
We support organizations in:
Assessing whether discussion papers are relevant to their products, technologies, or business objectives
Identifying strategic risks, opportunities, and emerging regulatory trends
Preparing structured and evidence-based responses to authorities
Contact us if you would like to discuss how this call for evidence may affect your organization, software portfolio, or planned regulatory activities.
Note
Check back regularly for updates on ongoing consultations, calls for evidence and emerging regulatory trends.