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

More information

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

Introduction

New legislation governing the development and authorisation of medicines for use in children aged 0 to 17 years was introduced in the European Union in January 2007.

The new piece of legislation — Regulation (EC) No 1901/2006 as amended (the 'Paediatric Regulation') — introduces sweeping changes into the regulatory environment for paediatric medicines, designed to better protect the health of children in the EU.

The Paediatric Regulation also brings in many new tasks and responsibilities for the European Medicines Agency, chief of which is the creation and operation of a Paediatric Committee within the Agency to provide objective scientific opinions on any development plan for medicines for use in children.

This new section of the EMEA website has been created to provide convenient access to all information relating to the Agency's work in the area of paediatric medicines, and will be updated regularly as new information becomes available.

 

Leaflet providing overview information about the role of the EMEA in the EU regulatory environment for paediatric medicines.

Leaflet providing an overview of the EMEA's role in the European regulatory environment for paediatric medicines.

Click the image to download a PDF version of the leaflet.

 

 

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The EMEA is committed to the provision of clear and comprehensive information to the public about all aspects of its work. Your views on this new web section, its contents and functionality are welcome, and may be submitted to our webmaster using this e-mail address: EMEA Webservices.