A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.
Study sponsors have offered contrasting views in a survey conducted last year on their experience of voluntary compliance with the provisions of the EU Clinical Trials Regulation (CTR).
The survey - undertaken between 18 July and 9 September under the Accelerating Clinical Trials in the EU (ACT EU)...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
