Paediatric medicines: Overview

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The European Medicines Agency has a number of important tasks and responsibilities relating to the development of paediatric medicines. These responsibilities, granted through the European Union (EU) Paediatric Regulation, enable the Agency to stimulate research into the uses of medicines in children and to lead to their authorisation in all age groups.

Before the Paediatric Regulation came into effect in 2007, many medicines authorised in Europe were not studied adequately or authorised in children. This caused difficulties for prescribers and pharmacists treating children, as well as for their patients and carers.

The Regulation introduced sweeping changes into the regulatory environment for paediatric medicines, designed to better protect the health of children in the EU. The main change was the creation and operation of the Paediatric Committee to provide objective scientific opinions on paediatric investigation plans (PIPs), development plans for medicines for use in children. 

This section of the website provides information for companies or individuals wishing to develop a paediatric medicine and requiring guidance for the approval of a PIP, together with other information relating to paediatric medicines. 

1. Research and development

2. Marketing authorisation

3. Post-authorisation

 

Working with international partners

The Agency works closely with its international partners on medicines for children:

Seeking the views of children and young people

In September 2012, the Agency launched a public consultation on its Concept paper on the involvement of children and young people at the Paediatric Committee.

The paper describes the Agency's plans to develop a framework of interaction describing how the views of children and young people can be consulted as part of the Committee's work.

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