‘So Far So Good’: EMA Talks Relocation, Staff Retention, Teleworkers And More
Around 125 staff members have left the European Medicines Agency because of Brexit but the regulator says this should not impact the core services related to the authorization and supervision of medicines for which it is responsible.
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Of the 60 or so applications the European Medicine Agency has received from drug companies hoping for more time to move their batch testing sites from the UK to the EU, about 50 have been successful.
The reduction in the European Medicines Agency’s activities since the UK voted to leave the EU nearly three years has impaired the regulator's ability to keep up with scientific and regulatory developments, and it is facing more staff losses as a result of its relocation to the Netherlands. However, the agency says it has managed to safeguard its core activities relating to the evaluation and supervision of medicines, and that the EU regulatory network should be able to adapt to Brexit-related changes without jeopardizing the quality of its work.
While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.