The European pharma industry group fears planned cuts in regulatory data protection and orphan drug exclusivity periods will hit innovation but says it is ready to work with legislators to close what it sees as an R&D gap between the EU on the one hand and the US and Asia on the other.
If the European Commission’s proposals for revising the EU pharmaceutical legislation are not changed they will accelerate negative trends such as the relative decline in R&D activity and in Europe’s global share of clinical trials, says EFPIA, the federation representing pharmaceutical companies in Europe.
The commission’s assertion that the proposals will improve access to medicines and vaccines while boosting scientific research and innovation is...
<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.
