The European Commission has come up with a workaround to address a current lack of functionality in the Clinical Trial Information System, while the European Medicines Agency has addressed technical queries on CTIS and the Clinical Trials Regulation.
Less than a month after compliance with the EU Clinical Trials Regulation became mandatory for new studies, there is no stopping the steady stream of new or updated regulatory guidelines being churned out to help trial sponsors navigate the new system. Two guidance documents were added to this list in February.
The European Commission issued updated questions-and-answers on the CTR on 17 February, mainly to address situations where the trial...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
