The directors of two key EU agencies outlined how they would work with the new HERA, and how they see their new roles under draft legislation aimed at strengthening their responses to health crises, at the recent European Health Forum Gastein conference. The European Medicines Agency also flagged up the potential role of real-world evidence in monitoring the safety and effectiveness of COVID-19 vaccines.
The European Medicines Agency says it plans to work closely with the new Health Emergency Response Authority (HERA) that has been created by the European Commission to make sure the EU is prepared for future health crises.
“We very much welcome HERA. We think that this is an important EU initiative,” said Emer Cooke, the EMA’s executive...
<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.
