Coronavirus Notebook: EMA Focuses On EU Drug Supply Amid Fears Of Second Wave
In this latest update to coronavirus developments in the EU, the European Medicines Agency outlines plans to monitor demand for medicines in anticipation of a possible second wave of the COVID-19 pandemic later this year. It has also updated its adverse drug reaction literature monitoring service to cover potential coronavirus treatments, and backed the use of ACE-inhibitors and sartans during the pandemic.
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Executive Summary: The European Medicines Agency’s management board has decided on December 2021 as the go-live date for the EU Clinical Trials Information System. It will also meet later this month to elect the EMA’s new executive director to succeed Guido Rasi.
The European Medicines Agency says good clinical practice inspections are indispensable even in the midst of a pandemic. It has set out requirements and specificities of undertaking inspections remotely where feasible.
The much-anticipated EU filing for Gilead’s COVID-19 treatment is being reviewed quickly by the European Medicines Agency.