The European Medicines Agency says that over 80% of the blocking issues and related workarounds affecting the Clinical Trials Information System have been resolved.
The mandatory use of the EU Clinical Trials Information System (CTIS) for new all study applications is on track for 31 January as planned, with the European Medicine Agency saying it has addressed the vast majority of issues that had been preventing the smooth working of the system.
Ongoing concerns about CTIS’ stability had prompted the EMA to offer its management board weekly updates on ensuring there were...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
