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European Commission

Press release

Brussels, 24 June 2013

Medicines for children: more research, more availability and more information compared with 5 years ago

Today, the Commission publishes a progress report on medicines for children covering the five years since the Paediatric Regulation came into force. This preliminary snapshot points to improvements in the paediatric medicines landscape: better and safer research, more medicines for children on the EU market and more information for parents and health professionals. Although it will take at least another five years for the full impact of the legislation to be understood, due to the long development cycles for medicines, the EU commitment to better medicines for children is clear.

Tonio Borg, European Commissioner for Health and Consumer Policy said: "The Paediatric Regulation was adopted to address a very serious gap in healthcare. Despite the fact that children make up over 20 % of the population, many of the medicines prescribed to them were not specifically studied and authorised for use in children. I am pleased to see that in five years, progress has been made on research and the safety of children's medicines, and I hope that this marks the beginning of a much needed paradigm shift."

Key objectives of the Paediatric Regulation:

The main provisions of the Paediatric Regulation [(EC) 1901/2006] were applicable from 26 July 2008, to meet three main objectives: 1) to ensure high-quality research into the development of medicines for children; 2) to ensure, over time, that the majority of medicines used by children are specifically authorised for such use with appropriate forms and formulations; and 3) to ensure the availability of high-quality information about medicines used by children.

How far have we come on meeting these objectives in the last five years?

Better and safer research

Before the Paediatric Regulation entered into force, many pharmaceutical companies considered the adult population as their main market. Research into the potential use of an adult medicine in children was often side-lined or not considered at all. Today's report shows that the situation is changing:

  1. Pharmaceutical companies now prepare paediatric investigation plans1 (PIPs) when developing a new product. By 2012 the European Medicines Agency (EMA) had agreed 600 PIPs.

  2. 33 of the 600 approved PIPs had been completed by the end of 2012, and it is expected that many more of them will be completed in the next five years.

More medicines available to children

  1. Since the Regulation came into force, 31 out of 152 new medicines have been authorised for paediatric use and many more authorisations are expected in the coming years.

  2. By the end of 2011, 72 new paediatric indications had been approved for already authorised medicines. Moreover, 26 new pharmaceutical forms were authorised for use in children.

More information on medicines used in children

To address the lack of adequate information on the use of medicines in children, the Paediatric Regulation requires that companies submit their data on safety of efficacy of products authorised for use by children, to the competent authorities.

  1. Since 2008, more than 18 000 studies on roughly 2 200 medicinal products have been submitted to the competent authorities.

  2. The analysis of those studies resulted in assessment reports on 140 active substances for medicines authorised nationally. For centrally approved medicines, the number is 55.

Next steps

Whilst the report shows considerable improvements in the developments of medicines for children the Commission will continue to monitor the implementation of the Paediatric Regulation, thereby also addressing some weaknesses or deficits that have been identified so far.

For more information on medicines for children:

Commissioner Borg's website:

Follow us on Twitter: @EU_Health

Contacts :

Frédéric Vincent (+32 2 298 71 66)

Aikaterini Apostola (+32 2 298 76 24)

1 :

A Paediatric Investigation Plan (PIP) is a research and development programme that aims to ensure that a new product is tested for its potential use in children and that such tests become an integral part of the overall product development.

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