European Medicines Agency Counts The Cost Of Brexit
Activities To Be Restarted With Fewer Staff
As the EMA settles into its permanent headquarters in Amsterdam, it hopes that new recruits will swell its depleted staff numbers. But much will depend on the necessary expertise being available, particularly following the loss of access to experts working at the UK regulator, the MHRA.
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A restructuring involving the setting up of four new task forces is aimed at improving how the European Medicines Agency responds to issues such as permanent staff reductions and challenges in regulatory science, digital business transformation, and clinical trial strategy.
Coronavirus Notebook: EMA Issues New COVID-19 Vaccine Safety Updates, Australia Assesses Comirnaty In Younger Children
The European regulator has warned of the risk of myocarditis, pericarditis and anaphylaxis with Novavax’s COVID-19 vaccine, Nuvaxovid, while Switzerland has updated its guidance on the use of COVID-19 medicines against virus variants. Iconovo has received funding to develop its ICOone nasal inhaler for use in pandemics in resource-poor settings.
Protection of IP and trade secrets and the need for clarity around issues such as the rules on access to data and the sharing of clinical trial data are seen as key issues in the European Commission’s plans for a European Health Data Space.