NorthWest Biotherapeutics Inc (NWBO)

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This is a big deal.

From 1 March 2024 we will be introducing a
process change to ensure applications are complete on initial assessment, or as soon after submission as possible. Additional guidance on the process change will be updated on the website.

Pressing the embedded link from the above paragraph, the following appeared. Please see additional bolding further below.

Established medicines

From January 2024, we publish data on numbers of regulatory assessments determined, average timescales at each stage, percentage within target and work on hand.

We understand the vital importance of efficient regulatory assessments and are taking urgent action to deliver improvements to timescales in established medicines.

Current timescales for regulatory decisions for established medicines in January were an average of 333 days for national routes (reduced from an average of 496 days in December, outside of the statutory timescale of 210 days) and an average of 195 days for reliance routes (reduced from an average of 253 days in December, outside the statutory timescale of 67 days). Applications through our new international recognition route are being assessed within expected timescales and will be added to our performance data publication, from March 2024.

We are taking significant steps to assess applications for medicines approvals within statutory timeframes. We will always prioritise applications according to public health need.

From 1 March 2024 we will be introducing a process change to ensure applications are complete on initial assessment, or as soon after submission as possible.

Upon receipt of an application MHRA will check documentation provided for technical completeness. If applications are incomplete, they will be refused.

Applications which are technically complete will continue on to scientific assessment and where there are issues raised a single request for information (RFI) will be sent out to the applicant (there will no longer be more than one RFI).

Applicants will have 60 calendar days to respond to the RFI.

There will be three outcomes from this point:

*If the response is complete the application will be determined[/color]

*If the response is inadequate on quality, safety or efficacy grounds, then the application will be referred to the Commission for Human Medicines for advice

*If no response is received within the timeline of 60 days, then the application will be refused.

Additional guidance on the process change will be updated next week.

In order to further improve the speed of our regulatory assessments, we request that, wherever possible, eligible national Marketing Authorisation applications submitted before 1 January 2024 that are awaiting first assessment are converted from the national route to recognition pathways. Applicants should email [e-mail] to register interest in this option.

The measures we are putting in place are already resulting in significant improvements, and we will continue to publish monthly updates providing applicants with transparent information on expected timescales.

Finally, we are committed to providing applicants with information and support. Please register to receive further information about our publications and events where we provide direct further support to applicants and which are led by Julian Beach, Interim Executive Director of Healthcare Quality and Access, MHRA.

https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines#established-medicines