Some countries in eastern Europe say that they should host the European Medicines Agency in order to respect the criterion of “geographical spread.” But many in western Europe say this principle should apply only to new agencies and that the criterion of business continuity at the EMA should take precedence.
Now that the bids are in from EU member states keen to host the European Medicines Agency after Brexit, the European Commission has the unenviable task of assessing the offers and submitting its conclusions to the European Council, with a final decision on the new location for this much sought after EU agency due in November.
19 countries have put themselves forward as the ideal candidate for the EMA when it moves out of...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
