Update: Expectations high for 'positive early access'/adaptive licensing recommendations in UK
This article was originally published in SRA
The expert group set up under the Strategy for UK Life Sciences to examine innovative approaches to regulation in healthcare is shortly due to publish "tangible and practical" recommendations on how the UK Medicines and Healthcare products Regulatory Agency might improve its approach to drug regulation.
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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.