The former head of the European Medicines Agency’s Data Analytics and Methods Task Force says sponsors should engage early with regulators to get feedback on the suitability of real-world data for a regulatory application. However, industry suggests developing a fitness-for-purpose framework with specific criteria to determine when RWD may be appropriate.
It is not possible for the European Medicines Agency to offer generic guidance on when it can accept real-world data (RWD), under what conditions or for which types of regulatory submissions.
“We cannot provide this information because this is really [decided] on a case by case basis, based on the research...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
