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. 

Paediatric medicines in the product lifecycle

Research and developmentMarketing authorisationPost-authorisation
Funding for paediatric studies  
Needs for paediatric medicines  
Paediatric clinical trials  
Paediatric investigation plans  
Rewards and incentives for paediatric medicines  
 Paediatric requirements for marketing-authorisation applications 
 Paediatric-use marketing authorisations 
  Annual reports on deferrals
  Deadlines for placing paediatric medicines on the market
  Paediatric requirements for variations and extensions to marketing authoriations
  Submitting results of paediatric studies

European collaboration

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children.

Enpr-EMA's main objective is to facilitate studies in order to increase availability of medicines authorised for use in the paediatric population. It provides access to European and international specialty and multi-specialty networks who can help developing a PIP and recruiting patients for clinical trials.

Working with international partners

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

Seeking the views of children and young people

The Agency acknowledges that it may be helpful to consult children and young people as part of the Committee's work. It has therefore established principles for the involvement of young patients, consumers, and their carers, including identifying in which situations it may be helpful to seek their input and defining what is expected from them when they are consulted.

This follows a public consultation on the concept paper on the involvement of children and young people at the Paediatric Committee.

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Factsheet: Supporting medicines for children in the EU

Report: How to better apply the paediatric legislation to boost development of medicines for children

Leaflet: Better medicines for children

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