Proposals to revise EU Guidance on first-in-human Clinical Trials
Recommendation
2/3 April 2025
From QbD to Process Validation
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The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper which has been released for public consultation. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until 30 September 2016.
The proposed changes take into account the evolution of practices in the conduct of first-in-human clinical trial studies and the lessons learnt from the tragic incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016.
The concept paper and the comments received from stakeholders will form the basis for an update of the guideline. A draft revised guideline is expected to be published before the end of 2016 for consultation.
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