MHRA: Launches AI Medicines Safety Survey for Drug Development

• The MHRA and its Regulatory Innovation Office are seeking views on AI's use in medicines development through a call for evidence.
• The survey aims to understand current AI applications, future plans, and barriers, including those related to data and regulation.
• AI holds potential to improve medicines safety evaluation, particularly in predicting ADMET by integrating diverse data.
• Findings will inform the 'Beyond ADMET: AI for medicines safety' regulatory sandbox, which was announced in June 2026.
• The deadline for submissions to the MHRA AI medicines safety survey is December 22, 2026, at 11:59 pm UK time.

By actively soliciting input now, the MHRA is positioning itself to create a regulatory environment that supports the safe and effective integration of AI into medicines development, ensuring patient safety remains paramount while harnessing technological advancements.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with its Regulatory Innovation Office (RIO), has launched a significant initiative to gather insights on the application of artificial intelligence (AI) within medicines development. This MHRA call for evidence AI seeks comprehensive perspectives from a wide array of stakeholders regarding the current and prospective uses of AI in enhancing drug safety. The MHRA AI medicines safety survey, which commenced on September 22, 2026, represents a proactive step by the regulator to understand the evolving landscape of AI technologies in this critical sector.

Organizations across the entire medicines development pathway are invited to contribute their views, including those involved in toxicology, preclinical and clinical research, and testing. Furthermore, input is welcomed from the life sciences, biotechnology, and dedicated AI sectors, as well as other related industries. The agency is particularly keen to understand how entities are currently employing, developing, or planning to implement AI-based approaches, alongside any associated challenges or barriers they encounter. The deadline for submitting responses to this crucial questionnaire is 11:59 pm UK time on Tuesday, December 22, 2026.

The core motivation behind this UK medicines AI development initiative is the recognized potential of AI to significantly improve the evaluation of medicines safety. AI technologies offer novel capabilities for predicting and assessing a medicine's absorption, distribution, metabolism, excretion, and toxicity (ADMET). By integrating traditional preclinical data with real-world and clinical data, AI can provide a more nuanced understanding that accounts for the inherent variability across different patient populations, disease states, and diverse clinical conditions.

This advanced analytical capacity is expected to revolutionize how medicines behave within the human body and perform in real-world scenarios. Ultimately, the goal is to enable earlier identification of potential safety risks, thereby enhancing AI in pharmacovigilance UK efforts and contributing to safer pharmaceutical products. The MHRA's interest extends beyond current applications to encompass future plans and areas where unmet needs could be addressed by AI, even for organizations not yet actively utilizing AI for safety-related purposes.

The MHRA AI medicines safety survey specifically aims to uncover the practical hurdles faced by innovators in this domain. Key areas of inquiry include challenges related to model development and validation, the complexities of accessing and sharing necessary data, and broader regulatory considerations. Understanding these barriers is paramount for the MHRA to foster an environment conducive to responsible innovation while maintaining robust safety standards.

Respondents are encouraged to provide specific examples from their organizational experiences to illustrate current practices, highlight challenges, and articulate priorities. This detailed feedback will be instrumental in shaping the future regulatory landscape. The comprehensive insights gathered will directly inform the development of the 'Beyond ADMET: AI for medicines safety' regulatory sandbox, an initiative first announced in June 2026, designed to provide a controlled environment for testing innovative AI solutions.

The findings from this MHRA call for evidence AI will serve as a foundational element for the UK AI drug safety regulation framework. Beyond informing the Beyond ADMET regulatory sandbox, the collected data will guide future regulatory work in this rapidly evolving field. It will also play a critical role in shaping how the MHRA and the MHRA Regulatory Innovation Office engage with innovators and researchers moving forward.

This engagement is anticipated to include workshops and other opportunities designed to explore key issues in greater detail, fostering a collaborative approach to developing effective and proportionate oversight. By actively soliciting input now, the MHRA is positioning itself to create a regulatory environment that supports the safe and effective integration of AI into medicines development, ensuring patient safety remains paramount while harnessing technological advancements.

Legal and compliance professionals advising pharmaceutical, biotech, or AI firms should note this MHRA call for evidence as a critical opportunity to influence the forthcoming UK regulatory framework for AI in medicines safety. Participation is key to shaping future compliance obligations and strategic development in this rapidly evolving area, particularly concerning the 'Beyond ADMET' regulatory sandbox.

Source: Original reporting via GOV.UK