Drugs Eligibility criteria for early access programs in France
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.
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.
Our experts at BlueReg are covering the Early Access Programs specific to France (ATU), and how to take advantage of it. The different subjects discussed in the webinar are : Why Early Access (ATU) for new innovative drugs in France…
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…