High-level negotiations are due to begin later this month on a draft regulation that will give the European Medicines Agency new powers to tackle supply chain issues amid health emergencies.
The European Parliament has called for the establishment of an interoperable EU database to monitor and report on medicines shortages that would facilitate access to, and the exchange of, information between the European Medicines Agency and national authorities.
The proposal is in the form of an amendment to a draft regulation that is intended to strengthen the role...
<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.
