The EU medicines network is advising drug companies to be proactive in screening their marketing authorization applications to determine whether regulatory action is needed in anticipation of the UK leaving the EU. More than 350 centrally approved products are affected.
The EU medicines network has issued guidance on some of the legal repercussions that drug companies may be faced with when the UK leaves the EU and the steps they should take to keep their products on the market.
Specifically, companies with centrally authorized and certain nationally authorized products may have to consider changing the terms of their marketing...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
