An EU review shows the great potential of regulator-led real-world evidence studies to address a range of research questions for regulatory decision making. It also provides learnings and recommendations for future improvements to the RWE framework being drawn up by the European Medicines Agency alongside the European medicines regulatory network.
A review of real-world evidence (RWE) studies commissioned by EU regulators over the past year and a half has identified room for improvement to better leverage the full potential of such studies in supporting regulatory decisions across the life cycle of a medicinal product.
The review report suggests, among other things, the need to better anticipate the need for such studies (eg, based on...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
