New pandemic-related responsibilities have been entrusted to the European Medicines Agency by a regulation published on 31 January. They include coordinating vaccine safety and effectiveness studies and setting up a European network of real-world data to help support health crisis preparedness and response.
The European Medicines Agency says it expects its new drug shortages monitoring platform to be up and running by early 2025. The platform will play a key role in allowing companies and member state authorities to provide information on the supply of “critical” medicines in the event of future health emergencies such as a pandemic.
Also being set up at the agency is a Medicines Shortages Steering Group (MSSG) that among other things will draw...
<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.
