Top UK regulator foresees upswing in use of parallel advice scheme
This article was originally published in SRA
The UK Medicines and Healthcare Products Regulatory Agency is confident that more pharmaceutical companies will make use before long of the parallel scientific advice scheme it has in place with the health technology assessment (HTA) body, NICE.
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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.