Hey everyone in the regulatory and pharmaceutical world!
Just dropping in to share the latest scoop from EMA: they've rolled out an update of the guidance on electronic submission of information for investigational medicinal products in XEVMPD. Take a peek here: guidance on electronic submission of information for investigational medicinal products in XEVMPD.
This document is all about guiding sponsor organizations through the submission process for medicinal product information in the Extended EudraVigilance dictionary (XEVMPD).
You know the drill: just like Marketing Autorisation Holders (MAH) have to submit info on their authorized meds to EMA, sponsors running clinical trials have to do the same for investigational ones.
The submission process covers a bunch of data elements, from development product entities to ATC codes, all managed through the Extended EudraVigilance Product Report Message (XEVPRM) schema.
In this process it is imperative to highlight the necessity of obtaining EU numbers for new products or active substances before or during the first clinical trial application. It's all about keeping things organized and cross-referenced, you know?
And hey, to get the submission game on point, make sure your sponsor squad is registered with EudraVigilance via Gateway or EVWEB.