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Paediatric medicines in the EU, the UK and the U.S.: regulatory framework in a nutshell

Author
Allos Rafi
Rafi Allos

Partner

London

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Carmeliet Tine
Tine Carmeliet

Senior Associate

Brussels

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Clerc Marylis
Marylis Clerc

Associate

Paris

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Eline D'Joos
Eline D'Joos

Junior Associate

Brussels

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Jacqueline Bore

Senior PSL / Life Sciences

London

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Image of Sapna Palla
Sapna Palla

Partner

New York

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18 October 2022

In a recently published Practice Note commissioned by LexisPSL, our life sciences experts look at the EU and the UK regulations in paediatric medicines, interspersed with insights from a US perspective. This Practice Note thoroughly analyses the legislative framework in both the EU and UK and provides an overview of the key obligations and incentives for pharmaceutical companies that were introduced to increase the number of paediatric studies and approved paediatric drugs. As a new proposal for the EU Paediatric Regulation is expected, the authors also undertake a critical review of the efficacy of the current European framework. 

For more information regarding these obligations and incentives, please find the full Practice Note on Paediatric medicines below.

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