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EMA’s Multinational Approach Brings All But Two Member States Into New Drug Assessor Fold

 
• By Maureen Kenny

The multinational assessment team (MNAT) approach aimed to involve more EU member states in the evaluation of new medicines. EMA views it as a success, although only about 10% of marketing authorization applications submitted for initial evaluation in 2015 involved MNATs. It will shortly be expanded to certain post-authorization procedures and is being promoted as a tool that will help the agency deal with Brexit fallout.

The European Medicines Agency says that its four-year-old, “under the radar” multinational assessment team initiative has already been a success: almost all eligible countries now have to some degree been directly involved in an assessment of new medicines under the initiative. It now is being expanded and is viewed by EMA as a means of compensating for the expected Brexit-related loss of UK expertise from the European pharmaceutical regulatory network,

The multinational assessment team (MNAT) concept introduced “a very innovative approach” to the assessment of medicines, the EMA told the...

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