Discussions on system of pediatric trials’ regulation

Cancer experts say that current system of regulations of children's cancer drug trials should be changed. They argue that the current system denies children new, potentially life-saving drugs and that children could have access to drugs that are currently only being tested in adults. 

The current European Union (EU) rules allow pharmaceutical companies to obtain exemptions from performing expensive drug trials in patients under the age of 18 - even if there is evidence it might benefit them. The problem is that this causes substantial delays in new drugs becoming available to the under-18s. It can even mean they are never formally authorised for use in children.

Original source.


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