NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

New from the MHRA:

From January 2024, we now publish data on numbers of regulatory assessments determined, average timescales at each stage, percentage within target and work on hand. In December 2023, whilst regulatory decisions for Type 1 and 2 Variations were within target we recognised that our performance on initial applications requires urgent improvement.

We are working to improve performance through:

- Increasing the quality of applications received, by creating clear guidance for applicants to improve right-first-time submissions
- Recruiting additional staff who continue through their training and accreditation.
- Identifying and acting on opportunities to speed up our regulatory assessment without compromising patient safety as follows;
- Offering eligible national Marketing Authorisation applications submitted before 1st January awaiting first assessment the opportunity to convert to MRDCRP.
- Continuing to ask companies to ensure that applications are correct by eliminating our most frequently seen error sources.
- The following three areas are where we see continue to see the highest error sources in applications:
- Use of bioequivalence and inappropriate biowaivers
- Specification and appropriateness of dissolution and impurities
- Requirement for nitrosamines assessment
- We are at the early stage of introducing a new process which has the potential to reduce timelines substantially. We will work with industry stakeholders to develop this process further.
- We are additionally restarting work that had begun to create improvements to timescales in reliance workstreams in 2023, as indicated in our performance data.