NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

(Quote below originally posted by DennisDave). In this case, “received” seems to be synonymous with “validated.” NWBO should potentially be the first to experience MHRA’s new efforts. (Aka: First Chair)

This week, Will Quince, a minister of state in the ruling Conservative Party, outlined the steps MHRA is taking to reduce turnaround time and set a target for how long it will take the agency to consistently meet the truncated timeline.

“MHRA is proactively engaging with the relevant Trade Associations on how best to improve the quality of marketing authorization applications, including workshops to support companies.

With the measures put in place, the MHRA anticipates that all priority and good quality dossiers that are compliant with legislative data requirements received from 1 January 2024 will be progressed within 150 days,” he said. MHRA’s guidance on 150-day reviews applies to all high-quality applications. As such, the guidance and Quince’s comment suggest that applications that cover all the required common technical modules and other information requested by MHRA will benefit from an accelerated review.

https://www.raps.org/News-and-Articles/News-Articles/2023/6/Euro-Roundup-MHRA-targets-150-day-turn-for-priorit