‘We’ll Manage,’ Danish Medicines Agency Head’s View On Brexit
He’d rather Brexit weren’t happening, but senior European regulator Thomas Senderovitz says the national medicines agencies across the EU are on track to cope with the expected loss of the UK – a key player – from the EU pharmaceutical regulatory network. There’s no alternative, and they’re putting lots of work into preparing for it, he tells the Pink Sheet.
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Not enough is known about how industry is preparing for Brexit when it comes to drugs approved via Europe’s mutual recognition and decentralized procedures. National regulators are urging companies to get their house in order.
Clusters of excellence, competition as well as co-operation, Brexit, and aiming high. Danish Medicines Agency head Thomas Senderovitz talks national agencies and engagement in an interview with the Pink Sheet.
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.