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Re: seekinganswers post# 806584

Saturday, 01/03/2026 12:37:31 PM

Saturday, January 03, 2026 12:37:31 PM

Post# of 818708

Only those with major unresolved issues go to CHM. Minor issues trigger requests for further information (RFIs) - seekingthewronganswers


But what you're stating, repeatedly, doesn't line up AT ALL with the reasons that the UK Gov itself states the MHRA consults with the CHM for, as cited below:

We operate fixed submission and assessment timetables for innovative medicines MA applications to facilitate consultation with the Commission on Human Medicines (CHM). Innovative medicines applications are defined as applications for:

New active substances (NAS), defined as active substances that have not been authorised in a medicinal product in the UK before
All biological products (derived or manufactured from a living biological system) including advanced therapy medicinal products (ATMPs), vaccines and biosimilars
New combinations of existing active substances
Orphan medicinal products
Conditional MA or MA under exceptional circumstances
Line extensions of any of the above (for example, addition of strengths, pharmaceutical forms or routes of administration)

https://www.gov.uk/guidance/submission-and-assessment-timetables-for-innovative-medicines-applications#:~:text=Print%20this%20page-,1.,forms%20or%20routes%20of%20administration)

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