EU regulation aims to improve research on medicines for children
The use of unlicensed and off-label medicines for children is widespread, yet over 50% of all pharmaceutical products have no scientific data for young people. With its Regulation on Medicinal Products for Paediatric Use the EU aims to promote the development of more medicines specifically for children.
To treat children effectively, and avoid unwanted side effects or under-dosing, precise data on the mechanism of action, efficacy or suitability are needed. Whereas vaccines and cough medicines for children are well researched, this is not the case for many asthma and epilepsy products, which were only tested for possible side effects in adults. Their active ingredients and formulas are also exclusively matched to adult bodies, and doctors are not given dosage recommendations for children or information on possible side effects or interaction with other medicines.
The development of medicines suitable for children is very expensive, as the under 15 years old group represents only 15% of the population. Moreover, trials involving children are complex and carry high risk. For example, unlike in the USA, in Germany very few parents allow their children to participate in studies.
The EU Regulation aims to improve the situation. Hildegard Debertin, Secretary General of Germany’s Stiftung Kindergesundheit said that, while the EU provides direction and removes barriers, the decision to develop medicines rests solely with pharmaceutical companies. The regulation under discussion will require them to develop more medicines suitable for children and increase tests of existing medicines regarding their effects on children. The proposal for a Regulation on Medicinal Products for Paediatric Use is ready to proceed to the 2nd reading in the European Parliament and should become law by 2007.
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