Two EU institutions have reached a deal on legislation that will give the EMA a key tool for monitoring medicines supply and preventing shortages in the event of a major public health crisis such as a future pandemic.
A new platform for monitoring medicines supply and to prevent shortages in EU in the event of a future public health emergency is to be set up by the European Medicines Agency under draft legislation that would greatly strengthen the EMA's role in crisis preparedness and management. It could, though, be several years before the platform is up and running.
On 28 October, the European Parliament and the Council of the EU (representing member state health ministers) reached a provisional...
<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.
