The European Commission has invested in several projects on novel real-world evidence methodologies, either via its key funding program for research and innovation or via public-private partnership initiatives.
With the emerging use of real-world data (RWD) and/or synthetic data in clinical trials to support safety and efficacy claims, the European Commission is keenly awaiting the first set of results from half a dozen projects it is funding to harness the use of such data for regulatory decision-making and health technology assessment (HTA).
The six projects were commissioned under Horizon Europe, which is the EU's key funding program for research and innovation. They...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
