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, ensuring 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 Paediatric Regulation dramatically changed the regulatory environment for paediatric medicines in Europe.

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 the paediatric-use marketing authorisation (PUMA) by companies, whcih the Agency, together with the European Commission, intends to address during its fine-tuning of the current implementation of the Regulation.

For more information, see:

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