EMA’s Multinational Approach Brings All But Two Member States Into New Drug Assessor Fold
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.
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The scope of the European Medicines Agency’s multinational assessment team initiative was originally due to expand in April from the pre-authorization to the post-authorization phase. It will happen next month instead.
Spurred by an apparent shift towards a more pro-business stance among government ministers, a number of top pharmaceutical executives and heads of UK industry bodies have publicly called for some form of regulatory alignment deal between the UK and the EU after Brexit.
The EMA has outlined some of the planning that has been going on in preparation for its relocation from the UK to another EU member state as a result of Brexit, including ongoing relations with the UK regulator, the MHRA.