The European Network of Paediatric Research at the EMA (EnprEMA) has launched a public consultation on its draft recommendations: “Cross-border access to paediatric clinical trials in Europe: preventing language exclusion.”
📄 About the draft recommendations
The draft recommendations examine how language and logistical barriers continue to limit children’s participation in clinical research across Europe, despite existing legislation prohibiting discrimination. They summarise current evidence showing that insufficient translation resources, the lack of validated translated study materials, implicit language requirements may restrict access to innovative therapies—particularly for children with rare diseases who may need to travel abroad to participate in clinical trials.
👥 Who should join the consultation?
The wider paediatric research community, including:
➡️ Clinical trial sites
➡️ Investigators
➡️ Research networks
➡️ Sponsors
➡️ Patient organisations and families
❓ Why public consultation?
Feedback from stakeholders will help identify gaps, strengthen the recommendations, and ensure they reflect both the available evidence and practical experience.
📩 How to submit comments?
➡️ Template: Download the submission form here
➡️ Email: Send your comments to enprema@ema.europa.eu
➡️ Deadline: 31 August 2026