Plans from the European Commission that would oblige all EU member states to consider joint clinical assessments have come under fire from Germany, France, Poland and the Czech Republic.
The European Commission’s proposals for greater cooperation on health technology assessments across the EU that would impose mandatory joint clinical assessments for some products are in breach of the EU’s subsidiarity and proportionality principles, say Germany, France, the Czech Republic and Poland.
The four EU member states have filed reasoned opinions setting out why they oppose the commission’s proposed ‘Regulation on Health...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
