EMA’s CHMP recommended fewer expedited approvals in 2023

EMA’s CHMP recommended 39 new active substances (NAS) in 2023, down from 2021’s peak of 54 but still well within the range of approval numbers in the last eight years. Last year did, however, mark the fourth straight year of fewer recommendations for expedited approvals, via the conditional and exceptional circumstances pathways, and a record year for application withdrawals.

The overall number of recommendations is not directly comparable the 55 new molecular entities approved by FDA in 2023. EMA does not separate cell and gene therapies from older modalities the way FDA does, so the European total includes Casgevy exagamglogene autotemcel while FDA counts CBER approvals separately. In addition to a few other small accounting differences, a major difference from the U.S. system is that while the EC nearly always follows the advice of CHMP, it has two months after the recommendation to grant authorization. That means some products recommended by CHMP in 2023 are receiving authorization 2024...