Posted by Michael Wonder on 22 Sep 2017
Market approval for drugs in the EU: time to change direction?
22 September 2017 - Since 1995, the EMA has been the EU authority responsible for assessing the efficacy, safety and quality of all medicines on the entire European market (around 500 million inhabitants).
Set up in London to harmonise the work of the national regulatory authorities (NRAs) for pharmaceuticals, the EMA serves 28 EU Member States at present, as well as the three countries (Iceland, Liechtenstein and Norway) included in the European Economic Area (EEA).
Since by law the EMA can only be based in a EU Member State, the result of the recent British referendum to leave the Union creates an unprecedented situation. Although the EMA recently claimed that this will not affect its procedures and work-streams at all, given the current political and economic crisis in the EU, it is hard to imagine that any such move will merely change only the EMA’s postcode.
