Clinical trials for medicines: expert advice

AI Summary

This regulatory guidance issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines compliance requirements under the Medicines for Human Use (Clinical Trials) Regulations 2004, as updated by the 2025 Amendment Regulations effective April 28, 2026. The guidance applies to all trial sponsors and investigators conducting clinical research in the UK. While not an inspection report detailing specific company violations, it identifies high-risk areas that trigger mandatory expert review, such as the use of novel compounds targeting the immune system, first-in-human trials with potential amplification effects, and substances with species-specific mechanisms. To maintain compliance, sponsors must proactively determine if their trial requires specialist committee advice. Required actions include notifying the licensing authority via email at least 28 days before submission and providing a full application through the Integrated Research Application System (IRAS) four weeks prior to expert meetings. Documentation must include a detailed biological rationale for human starting doses, transition strategies from animal models, and safety monitoring protocols. Adherence to these procedures extends the regulatory decision timeline by up to 90 days to ensure a thorough safety assessment.