EU Prepares To Release Major Pharma Legislative Overhaul

The much heralded – and oft delayed – revision of the EU pharmaceutical legislative framework is about to be published. R&D-based pharma firms as well as generic and biosimilar companies will be keeping a close eye on proposals such as reductions in regulatory data protection and market exclusivity periods.

Legislation on Direction Sign - Green Arrow on a Grey Background. — New EU medicines legislation is on its way • Source: Shutterstock

Wednesday 26 April will see the publication of the most wide-ranging overhaul of the EU medicines legislation since 2004 when Regulation No 726/2004 took effect, introducing a raft of changes including compulsory use of the centralized marketing authorization system for novel medicines such as new active substances, biologics and orphan drugs.

The regulation updated the EU framework for medicines to harmonize regulatory procedures across the bloc and allow the system to...