You are not familiar with the fast evolving Early Access French regulation and Exploitant Status ? Download the list of requirements for the Early Access program.

Known as Expanded Access Programs in the US, early access programs (EAP) allow access to medicines for certain patients before marketing authorization. The French early access program, authorization for temporary usage or temporary authorization (“autorisation temporaire d’utilisation” - ATU), was…

A European pharmaceutical company entrusted PharmaBlue (a BlueReg Company) as French «exploitant» with the responsibility of submitting, obtaining and implementing a French Early Access Program called “ATU” (Autorisation Temporaire d’Utilisation) for its orphan drug for patients in nominative and cohort…