A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.
EU regulators have issued a keenly awaited guideline explaining how study sponsors can protect commercially confidential and personal data in dossiers submitted to the Clinical Trials Information System (CTIS) under the provisions of the Clinical Trials Regulation. Compliance with the legislation became mandatory for all new trials on 31 January.
The guideline, developed under the Accelerating Clinical Trials in the EU (ACT EU) initiative, addresses a number of questions on...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
