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:
More medicines available to 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.
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:
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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.