Introduction The EU Paediatric Regulation Paediatric Committee Guidance for applicants Scientific advice Paediatric investigation plans (PIPs), waivers and modifications Paediatric-use marketing authorisations (PUMAs) Annual reports on deferrals Compliance Submission of paediatric studies (Articles 45-46) Opinions and decisions on PIP applications Background Class waivers Product-specific decisions Paediatric-related information Paediatric needs Paediatric clinical trials Priority list of off-patent medicines Scientific guidance Paediatric formulations Presentations EU paediatric network Global cooperation Member States International Workshops Related links

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Questions relating specifically to the authorisation of paediatric medicines may be submitted to: paediatrics@emea.europa.eu

 

PDCO Press Releases

Medicines for children

Medicines for children

Paediatric Committee

As part of the EMEA's implementation of the new Paediatric Regulation, a new scientific committee — the Paediatric Committee — was created within the Agency. At the beginning of July 2008, the Committee had its first anniversary. A report giving an overview of the achievements of its first year of operation, is available here.

The Paediatric Committee is responsible for providing opinions on the development of medicines for use in children, in accordance with the legislation.

Further information about the Paediatric Committee's mandate, rules of procedure, composition etc. is available in the Paediatric Committee section of this website.