An independent audit of the new EU Clinical Trials Information System has finally commenced, indicating that plans are on track for the EU Clinical Trial Regulation to be implemented from December 2021.
The European Medicines Agency’s new Clinical Trial Information System (CTIS) has reached a major milestone with the commencement of an independent audit that will verify whether the system is ready to support the implementation of the EU Clinical Trial Regulation (No 536/2014).
“The [CTIS] audit has commenced this morning as scheduled,” Fergus Sweeney, head of clinical studies and manufacturing taskforce at the...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
