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Q: Can anyone confirm whether a drug's supply chain (distribution) plans are a required part of the EMA application?

I assume such a final marketing authorization would consider aspects beyond clinical trial results. For example, who is going to supply the drug, does the drug require special handling or storage, what is the drug's shelf life, quality assurance plans, customer support plans, etc.

Further, I'd guess Geron's EMA supply chain partners may have their own Sections of the EMA application to complete & submit. If so, we'll need to finalize our EMA partner (ex-US licensee) in the coming months in order to submit an EMA application in 2H23.

HI, I can be of no help on this one, maybe Kmall

HI & Bp - was able to pull up two topics of interest with regards to the possible EMA "supply chain" question posed by Hoosier, although neither one seems overly pertinent to Geron's current situation focusing on pre-Regulatory submissions. Wholesale Distribution and Parallel Distribution. Both feel like the cart before the horse from what I've been able to glaze over. Perhaps post approval they hold more relevance, however, there could be a nugget of information in there I've overlooked?

I'm not quite sure if this is something along the lines with your question regarding the EMA Regulatory submissions process Hoosier? Again, far from my wheelhouse of knowledge. -Kmall


Wholesale Distribution:

https://www.ema.europa.eu/en/human-regu ... n-practice


Parallel Distribution:

https://www.gmp-compliance.org/gmp-news ... stribution