EMEA ISSUES EU ASSESSMENT PROCEDURE FOR CHILD IMMUNOTHERAPY PRODUCTS
March 1st, 2010
BY KEITH NUTHALL
THE EUROPEAN Medicines Agency (EMA) has issued European Union (EU)-wide guidance on assessing child immunotherapy medicines. This follows a tightening of controls by the German government, which is demanding all such pharmaceuticals are subject to marketing authorisation applications by this December (2010). An EMA note said: "Children are believed to derive potentially greater benefit from immunotherapy to inhalant allergens...Therefore, dedicated studies in children are considered necessary." Its new standard paediatric investigation ...
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