Brexit: EMA To Bolster Regulatory Reserves Ahead Of Relocation
European Medicines Agency head Guido Rasi explains the measures being taken to soften the blow of its departure from the UK, while a former health commissioner says that a decision needs to be taken as soon as possible on where the agency will be sited in order to ensure a smooth transition before Brexit.
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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.
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 Dutch government says it is well placed to host the European Medicines Agency, citing good travel links, the ability to host international organizations, and the prospect of continuity of the agency’s work. It wants a decision to be taken soon on the EMA’s future location.