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.
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...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
