The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.
The European Medicines Agency has commissioned the first set of real-world evidence (RWE) studies to be delivered under its ambitious big data project integrating various real-world databases across the EU under a single secure network called the Data Analysis and Real World Interrogation Network (DARWIN EU).
The EMA announced the launch of three RWE studies on 23 November after selecting the first ever “data partners” for...
<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>
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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
