A long-awaited regulation introduces major changes in the way that clinical trials are conducted across the EU, including a single application portal and new trial transparency requirements.
Almost 10 years after it was first drafted by the European Commission, the EU’s Clinical Trials Regulation finally takes effect today, ushering in a radically transformed environment for the submission, assessment, monitoring and reporting of trials.
Regulation No 536/2014 was originally proposed in 2012 as a replacement for the ageing Clinical Trial Directive, which the commission...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
