NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

Please see below for just one example of public discussion of MHRA being well behind on their targets for deciding on applications. This article was published in March 2024:

https://pharmaceutical-journal.com/article/news/mhra-approvals-miss-targets-by-more-than-100-days-data-show

MHRA data for January 2024 show that current timescales for regulatory decisions for established medicines in January 2024 were an average of 333 days for national routes (application for a UK, Great Britain or Northern Ireland marketing authorisation), falling outside the statutory timescale of 210 days. For reliance routes (the procedure that allows the MHRA to grant a licence, relying on approval in the European Union), a decision took an average of 195 days, versus the statutory timescale of 67 days.

The data also show that, in December 2023, timescales for authorisation approval of established medicines were 496 days, and 253 days for reliance routes.

As of 4 January 2024, there were also 1,167 overdue individual product licences (past the 210 day limit).