The European Medicines Agency (EMA) published on 5 May 2026 the agenda for a joint workshop with the European Network of Paediatric Research at the EMA (EnprEMA) and the Accelerating Clinical Trials in the EU (ACT EU) initiative, focusing on paediatric clinical trials. The workshop aims to address persistent challenges in conducting trials for children, including regulatory hurdles, recruitment difficulties, and the need for age-appropriate formulations.
The document, released by EMA's Paediatric Committee, outlines sessions on innovative trial designs, patient and family engagement, and the use of real-world evidence. It also includes discussions on streamlining ethics approvals and improving collaboration across member states. While the agenda does not set binding targets, it signals EMA's intention to prioritise paediatric research within the broader ACT EU framework, which seeks to modernise clinical trial conduct in Europe.
Stakeholder impact For pharmaceutical companies, the workshop may lead to clearer guidance on paediatric investigation plans (PIPs) and potentially reduced development costs through harmonised requirements. However, increased expectations for paediatric data could raise compliance burdens, especially for small and medium-sized enterprises. For children and their families, the initiative promises faster access to medicines tailored to their needs, but tangible benefits will depend on follow-up actions. National competent authorities may face pressure to align their approval processes, while patient advocacy groups are likely to push for stronger commitments.
Expected follow-up No immediate regulatory changes are expected from the workshop alone. However, outcomes may inform future EMA guidelines or revisions to the Paediatric Regulation. The European Commission is also expected to take note as it considers broader clinical trials legislation. The workshop is scheduled for late May 2026, with a summary report likely in the following months.
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