European payers have called for fast-track approval pathways and only limited use of conditional approvals in the upcoming reform of the EU’s pharmaceutical legislation. They also want to see data and market protection periods reduced to boost competition.
Forthcoming proposals from the European Commission on reforming the EU’s pharmaceutical legislation “should not mainstream” fast-track regulatory approvals and should limit the use of conditional marketing authorization, the European Social Insurance Platform (ESIP) and the Medicine Evaluation Committee (MEDEV) have warned.
The two groups also want to see amendments to the legislation that would improve access to medicines by boosting competition,...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
