Module232025

12/05/2025

EMA support

Procedural and scientific guidance SME user guide, Newsletter, EPARs

Joint parallel JSC with EU Health Technology Assessment (HTA)

Orphan Drug Designation

Paediatric Investigation Plan (PIP)

Qualification of novel methodologies

Marketing Authorization Application

HTA

ATMP Classification & Certification

Scientific Advice / Protocol Assistance

Academia entry point Academia@ema.europa.eu

Innovation Task Force (ITF) & EU Innovation Network

PRIority MEdicines ( PRIME designation)

SME Office Dedicated regulatory assistance

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Acknowledgements

Colleagues in the Paediatric Medicines Office

Ralph Bax Franca Ligas Roberto de Lisa Gunter Egger Chrissi Pallidis Giovanni Lesa

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