European CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
Medsafe has taken on board industry’s request for more time to implement its new labeling requirement for medicines containing opioids.
Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.