Europe – Brexit « having impact on EU drug development”

EMA and UK regulator both affected. In the EMA’s first annual report since its forced move from London to Amsterdam, executive director Guido Rasi pulls no punches about the impact of Brexit on medicines development.

The sacrifices made by the agency in 2018 as a result of the UK’s planned withdrawal from the EU have already hit activities such as the development and revision of guidelines which are “one of EMA’s key instruments for increasing the efficiency of medicines development in Europe” according to Rasi.

That has already affected a planned update of the EMA’s guidelines on the development of new medicines to treat haemophilia A and B, where there are a number of new therapies coming through development.

Also impacted are the proactive publication of clinical data, which has been suspended just as the benefits were starting to be realised, and much-needed upgrades to information systems that have had to be delayed, says Rasi in threport.