Paediatric Regulation

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The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years.

The Regulation aims to ensure that medicines for use in children are of high quality, ethically researched and authorised appropriately and improving the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults.

The Regulation dramatically changed the regulatory environment for paediatric medicines in Europe. Its main impact was the establishment of the Paediatric Committee (PDCO), which is responsible for coordinating the Agency's work on medicines for children. The Committee's main role is to determine the studies that companies must carry out on children as part of paediatric investigation plans (PIPs). The PDCO replaced the Agency's previous Paediatric Working Group.

Legislation

The Paediatric Regulation is comprised of:

  • Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use;
  • Regulation (EC) No 1902/2006, an amending regulation in which changes to the original text were introduced relating to decision procedures for the European Commission.

Five-year report

In June 2013, the European Commission published a report on the first five years of the Regulation. This concludes that paediatric development has become a more integral part of the overall development of medicinal products in the EU, with the Regulation working as a major catalyst to improve the situation for young patients:

The report includes an interim analysis of the experience based on a range of sources, including the results of a public consultation on the experience gained with the first five years of the Regulation, building on the Agency’s five-year report to the European Commission.

It also identifies some areas for improvement, such as the low uptake of paediatric-use marketing authorisations (PUMAs) by companies. More information can also be found in Successes of the Paediatric Regulation after five years, published by the Agency in 2013. 

Table of contents


Publications

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Background documents

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