Expanded Access is a treatment option that allows the use of an unauthorized medicine (investigational drugs). Under strict conditions, products in development (with ongoing clinical trial) can be made available to groups of eligible patients who have a disease with…
Thanks to early access programs, drugs are on average available in France 200 days before their first regulatory approval (FDA or EMA). In this context, early access programs can be extremely attractive for pharmaceutical companies developing life - transforming therapies.…
Download our latest Case Study: Exploitant services for MAA product You will learn more about: ▪ Exploitant status in France ▪ Exploitant services ▪ Pharmablue our Exploitant establishement
Main benefits of outsourcing "Exploitant" status : Reminder : French regulatory authorities require having an « Exploitant » authorized and established in France to manage an early access program in France or a Marketing authorization. Immediate activation of French Affiliate…
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