More clarity is needed on how member states plan to adapt their health technology appraisal procedures once the requirement kicks in for them to factor in EU-level joint clinical assessments.
Just exactly how member states will adapt their pricing and reimbursement procedures to take into account new EU-level joint clinical assessments (JCAs) remains unclear. Industry figures warn that more clarity is needed on the new procedures and an increase in resources.
The JCAs were the main feature of the EU’s Health Technology Assessment Regulation ((EU) 2021/2282), which was signed off in...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
