NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

hi Krisgo
sure no problem

************************
Dear MHRA,

I have a technical question regarding the UK national assessment procedure for ATMP Marketing Authorisation Applications (MAAs).

If an applicant submits an MAA based on a specific manufacturing process and facility configuration (for example, a particular cleanroom grade, equipment set, or manual workflow), and during the review the applicant updates the CMC package to incorporate a different manufacturing approach (such as a new automated system, equipment upgrade, or a move from Grade B to Grade C cleanrooms):

Does the MHRA require the revised manufacturing process to be fully qualified, GMP-inspected, and reflected in the manufacturer’s licence (MIA) before the MA can be granted?

Would the MHRA continue assessing the original manufacturing process described in the initial dossier, or would the review pause until the updated process is inspected, qualified and accepted?

In such cases, does MHRA classify the resulting timeline impact as a regulatory “clock-stop” on the sponsor’s side, rather than an MHRA backlog?

If the manufacturing process has been updated during the review, is it still possible for the MHRA to grant a Marketing Authorisation based solely on the original process described in the initial submission, even if the applicant no longer intends to commercialise that original process? Or must the MA reflect the updated commercial manufacturing route?

For clarity, this is a general procedural question about ATMP CMC management during an ongoing assessment. No company-specific information is being requested.

Thank you very much for your guidance.

Kind regards,

******************