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.
EU 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 EU, and updates on EU marketing authorization changes recommended by the CHMP.
More from EU CHMP Opinions And MAA Updates
More from Product Reviews
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
• By
Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.
• By
The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.