Draft legislation on strengthening the European Medicines Agency’s role in health crises has cleared another hurdle, and the European Commission is inviting companies to a matchmaking event aimed at scaling up the development and production of COVID-19 therapeutics.
Companies seeking EU approval of versions of authorized COVID-19 vaccines that have been modified to address variants of the SARS-CoV-2 virus have been advised to contact the European Medicines Agency three months in advance of their planned submission. They have also been told to seek scientific advice as early as possible to discuss the choice of variant.
Modified vaccines will be assessed as variations to the original marketing authorization (MA) under an expedited timetable and the could...
<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.
