Enpr-EMA launches Public Consultation on pediatric clinical trials in Europe

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has launched a public consultation on recommendations to improve cross-border access to pediatric clinical trials in Europe, available until August 31, 2026. 

The recommendations highlight how linguistic and logistical barriers continue to limit children's participation in clinical research, despite regulations prohibiting discrimination. Summarizing evidence that inadequate translation resources, non-validated tools, and implicit linguistic requirements may restrict access to innovative therapies, especially for children with rare diseases who may need to travel abroad to participate in trials. 

Access the document with the recommendations, available here.

Who can participate? Researchers, healthcare professionals, sponsors, patient organizations, families, and other stakeholders.

How can I share comments and contributions? By completing the available template and sending it to the email: enprema@ema.europa.eu Access the template, available here.

What is the submission deadline? Until August 31, 2026.

The Enpr-EMA aims to identify and overcome challenges limiting the participation of children and young people in clinical trials conducted in other European countries, promoting greater equity in access to clinical research and innovative therapies. 

Learn more on the Enpr-EMA website.