EMA adopts guideline on requirements for investigational ATMPs in trials

Article summary

The European Medicines Agency (EMA) has adopted a guideline outlining quality, non-clinical, and clinical requirements for investigational advanced therapy medicinal products (ATMPs) in clinical trials. The guideline, effective from 1 July 2025, covers gene therapy, cell therapy, tissue engineered products, and combined ATMPs. EMA has emphasised a risk-based approach for data evaluation and the importance of quality development. The agency has incorporated public feedback, including references to ICH E11 guidance for paediatric populations and device-drug combination ATMPs. EMA encourages early guidance seeking and notes that inadequate quality development may compromise clinical trial data usability for marketing authorisation applications.