Paediatric Regulation

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;
• 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 July 2012, the Agency prepared a five-year report to the European Commission, which reflects on the experience acquired as a result of the application of the Paediatric Regulation.

The report summarises the areas of success and lessons learned of the implementation of the Regulation since it came into operation:

• Between 2008 and 2011, 13 new medicines as well as 30 new indications and nine new pharmaceutical forms of existing medicines were authorised for use in children. These authorisations were made on the basis of paediatric investigation plans (PIPs) agreed by the Agency’s Paediatric Committee (PDCO).
• By the end of 2011, the PDCO had adopted opinions on compliance for 29 agreed PIPs. This means that the full PIP was completed for these medicines.
• National patent offices in 16 Member States granted a six-month patent extension to 11 medicines, i.e. a total of 105 national supplementary protection certificates.

The report also identifies areas for improvement, stating that some paediatric therapeutic areas that predominantly affect children have been neglected in terms of pharmaceutical research. The report also notes that pharmaceutical companies do not make best use of the opportunities for early regulatory dialogue.

Back to top