The Paediatric Regulation has governed the development and authorisation of medicines for paediatric use since entering into force in 2007. Its objective is to improve the health of children in Europe by addressing the low level of research and development into medicines for children by pharmaceutical companies.
The Regulation is structured around three main objectives:
- More medicines for children
- Better product information
- More paediatric research
The Regulation sets up a system of obligations, rewards and incentives to encourage manufacturers to research and develop medicines for children’s specific therapeutic needs. It obliges companies to screen every new product they develop for its potential use in children, to progressively increase the number of products with paediatric indications. This is done at the earliest stage of development through the 'Paediatric Investigation Plan’ (PIP) which is an obligatory part of overall product development. That plan needs to be agreed with the European Medicines Agency, which is supported by its Paediatric Committee.
In addition, the Regulation promotes high-quality information and high-quality research into medicines for children through measures, such as:
- An EU network of networks of investigators and trial centres carrying out paediatric research;
- An EU inventory of paediatric needs;
- A public database of paediatric studies; and
- A requirement for companies to submit any existing paediatric studies on authorised medicinal products for scrutiny by regulatory authorities.
Review of EU paediatric legislation
Action plan for supporting development of medicines for children
In December 2020, the European Commission and EMA published a progress report on their joint action plan to support the development of medicines for children in Europe.
Concrete achievements in several areas have been made in cooperation with various stakeholders. They concern for example the publication of overviews of paediatric medical needs in selected therapeutic areas, the release of recommendations to foster timely completion of paediatric investigation plans (PIPs), and the improvements of the handling of PIP applications.
At the same time, works continues and further progress updates will be made available.
In October 2018, the European Commission and EMA published a joint action plan to support the development of medicines for children in Europe.
The action plan aimed to increase efficiency of paediatric regulatory processes in the current legal framework and boost availability of medicines for children. It contained 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 addresseed challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Regulation. It also took 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 2017 Paediatric Report
In October 2017 the Commission presented to the European Parliament and the Council a comprehensive report on progress made in children's medicines 10 years after the Paediatric Regulation came into force:
- State of Paediatric Medicines in the EU - Report from the Commission to the European Parliament and the Council
The report is complemented by the following documents:
- A technical 10-year report to the European Commission prepared by the European Medicines Agency together with its Paediatric Committee
- A study on the economic impact of the Paediatric Regulation
The 2017 Commission report built moreover on the results of a public consultation.
The 2013 progress report on the Paediatric Regulation covered the initial five years of its applicationIt is based on a public consultation document. A summary of the replies is available here. The Consultation built on the Five-year Report to the European Commission drafted by the European Medicines Agency with its Paediatric Committee.
The Commission publishes on an annual basis a report on companies and products that have benefited from any of the rewards and incentives of the Regulation and companies that have failed to comply with obligations of the Regulation:
- Report covering 2020
- Report covering 2019
- Report covering 2018
- Report covering 2017
- Report covering 2016
- Report covering 2015
- Report covering 2014
- Report covering 2013
- Report covering 2012
- Report covering 2011
- Report covering 2010
- Report covering 2007-2009