Last week I gave a snapshot of the formal process undertaken by the European Medicines Agency (EMA) to review a Marketing Authorisation Application (MAA) dossier under the Centralised Procedure. While this provides some context, looking at historical review timelines provides some sense of how long a future application may take. This is far from an exact science, but given the queries we have received of late on approvals timelines, I felt it appropriate to provide some internal perspective.
The EMA’s timelines are confidential, with only set time points at which companies are allowed to publish information (CHMP meetings in particular). Once a drug has been approved by the EMA, however, the Agency issues a summary of the entire review process, known as an EPAR, or European Public Assessment Report. This document outlines the timeframes required by the EMA to perform the review, along with the names of the co-rapporteurs and a summary of the product in some depth, much of which likely reflects the dossier submitted, albeit in an abbreviated version. (The EPARs are published online by the EMA and are free to download.) (more…)