Module232025

12/05/2025

ACT EU workplan 2025 - 2026

41 https://accelerating-clinical-trials.europa.eu/document/download/0f53c5bd-292f-4407-b891-6259f2d187aa_en?filename=ACT%20EU_workplan%202025-2026.pdf

41

Conclusion - Paediatric drug development

*

Public health need

EU Paediatric Regulation

Collaboration to support access

Research and Development (R&D)

How to facilitate timely developments in ecosystem

Need to exchange on challenges related to joint ambition

Regulatory data needs

to authorisation, access and practice change

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* https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R1902&qid=1621344480633

42