Brexit Won’t Delay Drug Approvals, EMA’s Rasi Reassures Industry
The EU’s centralized drug approval process will not be disrupted regardless of the number of employees the European Medicines Agency might lose when it relocates from London to Amsterdam, Guido Rasi pledged yesterday at the DIA Europe 2018 conference.
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The EMA has completed the reallocation to the EU27 member states of more than 370 centrally authorized drugs for which the UK was rapporteur or co-rapporteur. The move has been necessitated by Brexit, which means the UK will no longer play an active role in new drug evaluations at the EMA.
An EU parliamentary committee has OKd the EMA’s move to Amsterdam, but with caveats. MEPs are unhappy with the way the agency’s new home was decided and have called for changes to the procedure used to choose EU agency locations in future.
Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.