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.

The European Medicines Agency's key scientific panel, the Committee for Medicinal Products for Human Use (CHMP), meets once a month and among other things adopts positive or negative opinions on marketing authorization applications (MAAs) filed through the centralized procedure for new molecular entities (NMEs), biosimilars and generic medicines. CHMP opinions are sent to the European Commission, which makes a final, legally binding decision, usually within 67 days.

The CHMP at its monthly plenary meetings also assesses requests for modifications or extensions to existing marketing authorizations.