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January 28, 2007
More drug safety for children
by Michael Martell
New law cuts off standardised off-label use
On January 26, 2007 the new EU Regulation on Paediatric Medicines, adopted on December 12, 2006, has come into force. The regulation became effective immediately in each state of the European Union.
Finally, one might say. In the EU, fifty per cent or even more of medicines used in children have never been actually studied in this part of the population, but only in adults, not necessarily in the same indication (or the same disease). Doctors did not have a choice but guessing the right level of dose for their small patients or whether the drug would be suitable for children at all. The new law puts an end to the standardised Off-label use.
Because clinical trials with children take more time and tend to be more difficult, currently, pharmaceutical companies dispense with them.
In the future however, there will be some major changes for pharmaceutical companies regarding the approval for children’s drugs:
As of now, a new drug application (NDA) will have to contain clinical research data for children and adolescents, or, alternatively, needs to be indicated as unsuitable for children. The clinical research has to be based on a special paediatric investigation plan, approved by a new Committee of the EMEA with scientists of different member states of the EU. In exchange, pharmaceutical companies will receive a six-month patents extension to market the approved medicines. The patents extension will also apply for approved medicines if a paediatric investigation plan is provided.
Günter Verheugen, Vice president of the European Commission, said: "I very much welcome this landmark agreement.”
For further information click here:
http://www.medicalnewstoday.com/medicalnews.php?newsid=60672
http://www.emea.eu.int/htms/human/peg/prgfaq.htm
Posted by michael_martell at January 28, 2007 01:21 PM
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