Monday, November 14, 2022 6:59:19 PM
Modules of a MAA
1. Administrative and Prescribing Information
* Application form
* Brief overview of Product characteristics
* Labeling text and mock-ups
* Experts’ information
* Risk assessments related to the environment
* Orphan market exclusivity information
* Description of the pharmacovigilance system
* Risk management plan
2. High Level Summaries
* Quality
* Non-clinical overview
* Non-clinical summary
* Clinical overview
* Clinical summary
3. Quality Documentation
* References
* Body of data
4. Non-Clinical Documentation
* Reports of conducted studies
* References
5. Clinical Documentation
* Tabular listing of conducted studies
* References
They are normally submitted in a Common Technical Document:
It seems pretty clear that Advent has been tasked with preparing the required manufacturing information for the “quality” module of the MAA in the UK, which is also known as the CMC (Chemistry Manufacturing Controls) section of a BLA in the US, and it’s extremely extensive. For anyone that’s interested, there’s a pretty good overview of what’s required here:
ISPE Introduction to CMC Regulatory Affairs
https://www.ispeboston.org/download/educational_presentations/2016/2016-11-10-Regulatory-Symposium-BMamidipudi.pdf
And a pretty good overview of the Rolling Review route in the UK here:
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