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Slowly Does It: The EMA’s Approach To Expanding Multinational Drug Assessment Concept

Executive Summary

The European Medicines Agency’s multinational approach to drug assessment under which new marketing authorization applications are evaluated by teams formed according to expertise rather than by country has proved popular and is now being expanded to the “complex” post-authorization phase. The multinational assessment team (MNAT) concept will be broadened in phases, starting in April. Issues relating to sustainability, knowledge transfer and payment of fees to participating national authorities all have to be considered.

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