NorthWest Biotherapeutics Inc (NWBO)

[Red_Right_Hand]

CHM meetings are part of the MHRA process. CHM consists of subject matter experts (i.e., scientists/doctors) who advise the MHRA. There is not an extra step, or a need for MHRA to refer MAAs to CHM to be denied or approved, because the CHM is integrated into the MAA review process, where their role is to provide their opinion about approval/refusal of the MAA. The CHM does not approve or refuse. The CHM provides their opinion to MHRA about whether to approve or refuse, and why. The CHM advises but the MHRA decides.

https://www.gov.uk/government/organisations/commission-on-human-medicines/about

We’re responsible for:

-advising on applications for both national and European marketing authorisations
-considering further representation against our provisional advice in respect of national applications
-advising on the need for, and content of, risk management plans for new medicines
-advising on the impact of new safety issues on the balance of risks and benefits of licensed medicines - eg adding warnings, restricting or suspending use of a medicine
-advising the licensing authority on changes to legal status of marketing authorisations