Consultations: Medicinal Products for Paediatric Use
Name: Proposals for a Regulation on Medicinal Products for Paediatric Use
Source: European Commission
Date: April 2004
Following European enlargement in May 2004, there are now an estimated 100 million children living in the UK. Physiologically, children are not just 'mini-adults'-they respond differently to medicines. In many circumstances drugs that have only been tested on adult populations may be inappropriate, or even dangerous when used in a paediatric population. It is estimated that between 50 per cent and 90 per cent of medicines used in children have never been specifically evaluated for use in this age group.
Unlike the USA there is currently no requirement within the EU for people producing medicines to evaluate whether existing adult drugs are likely to be of use in children. Because the market in developing medicines for children is small and thus of low commercial interest, the adapting existing medicines to meet the needs of children.
The European Commission launched a consultation in April 2004, on its proposal for a regulation on medicinal products for paediatric use.
It is hoped that such regulations will increase the development of medicines for use in children, ensure that these medicines are subject to high quality research and are appropriately authorised for use, and lead to improved information on the use and impact of new medicines in younger populations.
For more information please read the consultation response in full.
To find out more about our position on access to treatment in the UK, go to the Cancer Treatment and Clinical section of our briefings.
A - Z index
Contact us
Donate now
Glossary
Print this page