The European Commission has launched the process for reshaping and addressing the long-standing weakness in the EU’s pharmaceutical legislation. It has listed in a roadmap the issues it wants to address as it considers policy options for reforms.
The European Commission has formally kick started its much-publicized plan to revise the EU’s long standing pharmaceutical legislation and deliver the ambitious changes outlined in the pharmaceutical strategy it adopted last November.
As a first step, the commission has published for consultation a “combined evaluation roadmap/inception impact assessment” for the evaluation...
<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.
