EU CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.
The European Medicines Agency has been asked to re-examine its rejection of the EU marketing application for Ipique, which, if approved, could become the first drug containing bevacizumab to be authorized for use in neovascular (wet) macular degeneration.
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is being introduced in New Zealand, where the new coalition government is working to repeal last year’s landmark Therapeutic Products Act.