EMA TELLS EU PHARMA COMPANIES TO PREPARE TO USE NON-EUROPEAN DATA IN MARKET AUTHORISATIONS
October 1st, 2012
BY KEITH NUTHALL
THE EUROPEAN Medicines Agency (EMA) has told pharmaceutical companies to plan for European Union (EU) marketing authorisation applications using data from proposals made outside the European Economic Area (EEA). This is the EU plus Norway, Iceland and Liechtenstein and comes in revised EMA guidance on market authorisations for so-called 'biosimilar' medicines that have similar active ingredients to pharmaceuticals approved elsewhere. Until now, EMA has only allowed pharmaceutical companies to use previously collected data culled from tests for ...
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