After years of wrangling, the legislative process for new regulation on greater cooperation on health technology appraisals across the EU has entered its final stages, with parliament expected to adopt the legislation soon.
The Council of the European Union has voted to adopt new legislation that will see the eventual introduction of joint clinical assessments that can be used in health technology appraisals (HTAs) in the EU. It will also introduce joint scientific consultations.
The vote, on 9 November, comes after the European Parliament and the council reached an agreement on the contentious European...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
