Paediatric medicines: Overview
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
Action plan for supporting development of medicines for children
In October 2018, EMA and the European Commission published a joint action plan to support the development of medicines for children in Europe:
The action plan aims to increase efficiency of paediatric regulatory processes in the current legal framework and boost availability of medicines for children. It contains actions in five key areas, including:
- identifying paediatric medical needs;
- strengthening cooperation between decision makers;
- ensuring timely completion of paediatric investigation plans (PIPs);
- improving the handling of PIP applications;
- increasing transparency around paediatric medicines.
The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Regulation. It also takes into account the ideas on How to better apply the Paediatric Regulation to boost the development of medicines for children collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.
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:
- it holds regular meetings with the United States Food and Drug Administration (FDA) within the paediatric cluster to exchange information on applications and topics related to development and to help support global development plans for paediatric medicines. For more information, see Partners & networks: United States: Cluster activities.
- it participated in the launch of the World Health Organization (WHO) initiative Make Medicines Child Size.
- it is a member of the Paediatric Medicines Regulators' Network (PmRN). This is a network of national medicines regulatory authorities set up by the WHO in 2010, which promotes the quality and availability of medicines for children and contributes to capacity-building.
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 .