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…
Advanced Therapy Medicinal Products (ATMP) are promises medicines for untreatable and high burden diseases where conventional approaches are inadequate such as cancer, cardiovascular diseases, musculoskeletal conditions, or immune system disorders1. To allow patients timely access to these new therapies a…
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.…
Background: In February 2022, the EMA initiated the establishment of the Coordination Centre for the Data Analysis and Real-World Interrogation network (DARWIN EU®). In this context, EMA has organised a multi-stakeholder information webinar to: introduce DARWIN EU and…
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),…