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

 
• By Maureen Kenny

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.

The European Medicines Agency is taking a step-by-step approach to expanding an initiative that for the past four years has enabled national authorities to participate in the initial assessment of new medicines through the involvement of single experts rather than via an entire team.

Until now, the initiative has applied only to procedures under the pre-authorization phase. Starting in April, the agency is expanding its multinational assessment team (MNAT) initiative to the post-authorization phase....

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