EU CHMP Opinions and MAA Updates
Executive Summary
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 EU, 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 EU 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.
The table below provides an overview of decisions on new marketing applications, applications to extend the indication of existing marketing authorizations and requests for the re-examination of negative opinions the CHMP has adopted. It also covers the withdrawal of MAAs by companies.
The table has now been updated with products that the CHMP discussed at its meeting in January. (Also see "EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos" - Pink Sheet, 27 Jan, 2023.)
*The European Commission usually makes a final, legally binding decision on products for COVID-19 much faster than 67 days, sometimes within hours of the CHMP adopting an opinion.