Thursday, April 23, 2026 6:28:54 AM
MIA UPDATE!
I dont think anyone has posted this yet. All props to Henry Muney for finding this! The Advent Bioservices MIA certificate has just been updated LINK here.
I believe that this is an extremely positive sign!
From what I understand, just before MA being granted or at the exact same time, the MHRA must legally tie the specific commercial product to the manufacturing site. This involves updating the confidential sections of the MIA to include the finalised MA number, the approved commercial release specifications, and the formal shift from investigational manufacturing to full commercial distribution.
The only visible change on the entire document since the last update is the authorisation issue date shifting from 15/12/2025 to 22/04/2026. From what I have researched, this is completely in-line with preparation for a marketing authorisation and it is entirely normal for this specific type of update to happen completely under the hood without altering the visible text of the public certificate.
Also I think it’s very telling that this time (unlike December) it is just an MIA update not both MIA and MIA(IMP). Because the MIA(IMP) was left untouched, whatever the MHRA just approved or altered has absolutely nothing to do with clinical trials, compassionate use, or specials program. The update is exclusively relevant to commercial operations. Now in hindsight I believe the December update to both certificates was most likely to reflect the new company ownership.
GLTA
I dont think anyone has posted this yet. All props to Henry Muney for finding this! The Advent Bioservices MIA certificate has just been updated LINK here.
I believe that this is an extremely positive sign!
From what I understand, just before MA being granted or at the exact same time, the MHRA must legally tie the specific commercial product to the manufacturing site. This involves updating the confidential sections of the MIA to include the finalised MA number, the approved commercial release specifications, and the formal shift from investigational manufacturing to full commercial distribution.
The only visible change on the entire document since the last update is the authorisation issue date shifting from 15/12/2025 to 22/04/2026. From what I have researched, this is completely in-line with preparation for a marketing authorisation and it is entirely normal for this specific type of update to happen completely under the hood without altering the visible text of the public certificate.
Also I think it’s very telling that this time (unlike December) it is just an MIA update not both MIA and MIA(IMP). Because the MIA(IMP) was left untouched, whatever the MHRA just approved or altered has absolutely nothing to do with clinical trials, compassionate use, or specials program. The update is exclusively relevant to commercial operations. Now in hindsight I believe the December update to both certificates was most likely to reflect the new company ownership.
GLTA
Bullish
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