The Tricky Task Of Bringing Smaller EU Countries Into The Fold
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.
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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.
Companies still need to replace the UK as their reference member state for around 6,000 products in Europe’s decentralized and mutual recognition procedures. Of the switches that have been completed so far, many have gone to Germany.
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.