Five countries appear to be ahead in the battle to host the European Medicines Agency after Brexit, judging by the results of a European Commission assessment and an EMA staff survey, although much horse-trading among member states is expected before the winner is announced in November.
The European Commission has published its assessment of the 19 bids submitted by EU member states to host the European Medicines Agency when the much sought-after organization is forced out of London by Brexit in 2019.
The assessment, which will be used by member states when they vote on the new location in November,...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
