Download the 5 must-know for US Biotechs looking to run Early Access Programs in France: Regulatory Constraints - The Exploitant Financial and Resources Constraints Administrative and Management Constraints New Regulations in 2021 French fast evolving regulations
An American pharmaceutical company starting to build its European affiliates entrusted PharmaBlue with the responsibility of submitting, obtaining, and implementing a French Early Access Program for its orphan drug. PharmaBlue support them for the whole process of submission (advice, writing…
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…
About the "Exploitant" status French regulatory authorities require having an « Exploitant » authorized and established in France to manage an early access program in France or a Marketing authorization. At the European level, there are three separate positions: The…
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…