EMA Tackles Tough Job Of Filling UK Void In Working Parties
The European Medicines Agency has started the difficult task of finding replacements for the UK chairs and members of its numerous working parties and groups who are having to vacate their position because of Brexit.
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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.
Pharma is clearly worried about how the UK's exit from the EU will disrupt both the European Medicines Agency's capacity for drugs reviews and the pan-European regulatory environment. Former EMA executive director Thomas Lönngren explained to the Pink Sheet during the BIO-Europe Spring meeting that the relationship between EMA and the US Food and Drug Administration could be a model the UK regulator, the MHRA, could adopt if the British take a hard Brexit route.
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 The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.