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 Marketing Authorisation holder (MAH), responsible for product marketing, pharmacovigilance, information-advertising, batch tracking and, where necessary, recalls. The manufacturer, with authorization granted by the Member State in which the manufacturing operations under its responsibility are carried out. The ..read more

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 Access to rare skills and experienced team in France Exploitant for your early access program as third party Exploitant for your Marketing Authorization (MA) as third party Peace of mind operations on French market Transition after MA Approval and help to build your own French set-up   About the ..read more

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 originally initiated to enable the sale of certain medicinal drugs offering solutions to serious or rare diseases ahead of any pricing negotiations, market permission or reimbursement. The ATU program was initially designed to provide access to new therapies for human immunodeficiency viruses ..read more

Late-stage American biopharmaceutical companies in late-stage development for their product are logically interested in the European market, and we clearly see a trend of companies looking to expand in Europe by themselves rather than partnering with an establishment based there.   If we take a quick look at the map representing market share of new drugs launched between 2015 and 2020, it is quite easy to understand that Europe certainly is a market of interest.     If you want to ensure that your registration & launch strategy in Europe are as successful as possible, it’s ..read more