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10 November 2009
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Parliament backs directive for more child medicine R&D 

Published: Wednesday 7 September 2005    | Updated: Friday 3 November 2006   

Parliament has voted, with an overwhelming majority, in favour of a regulation stimulating research into and development of medicines for children. 

The European Parliament plenary has confirmed the Parliament Enviornment Committee's (ENVI) stand (see EurActiv 15 July 2005) and voted in favour of the paediatric medicines directive. 

The directive, the aim of which is to guarantee that medicines administered to children are suitable for them, requires pharmaceutical companies to conduct clinical trials involving children before authorisation of drugs. As compensation for these extra costs and as incentive for more R&D, the companies will be granted a six-month extension of their patent.

The Parliament also backed the ENVI Committee's wish to see the European Medicines Agency (EMEA) establish a network of researchers to avoid duplicating research or tests on children and called for the creation of a special EU programme for research into medicines for children, to be called MICE (Medicines Investigation for the Children of Europe).

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