Health care and medicines are among the priorities outlined by the new presidency of the Council of the EU for the first half of 2023.
Sweden, which took over the rotating presidency of the Council of the European Union on 1 January, says it will prioritize a number of health-related initiatives in the first half of the year, including the revision of the EU pharmaceutical legislation, revisions to the regulations on orphan and pediatric medicines, and a new fee structure for the European Medicines Agency.
The presidency said it would also make efforts to keep the issue of antimicrobial resistance “at the top of the...
<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.
