Revised transparency rules for the EU Clinical Trials Information System aim to deliver earlier publication of key documents of interest to patients and researchers, including study protocols, as well as a significant simplification of the system for sponsors.
The European Medicines Agency has adopted revised transparency rules to rationalize the amount of study data that sponsors have to make public via the Clinical Trials Information System (CTIS), the EU portal for making trial-related submissions under the provisions of the Clinical Trials Regulation (CTR).
The emphasis is on publishing fewer documents, but ones that are more meaningful to stakeholders, earlier.
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
