A Q&A with Thomas Müller, adaptive licensing sceptic from Germany’s health technology assessment body, the G-BA
This article was originally published in SRA
German health technology assessor Thomas Müller put the cat among the pigeons recently when he suggested that adaptive licensing – under which certain new drugs would be approved earlier on in the development process than at present and on the basis of less evidence – could be perceived as a lowering of standards at the European Medicines Agency.
You may also be interested in...
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
Bayer has failed to convince the European Medicines Agency that its marketing authorization application for finerenone should be fast-tracked through the EU's centralized review process. There were other successes, though, although Janssen is keeping us guessing over its MAA for amivantamab. These and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.