EU leaders have endorsed the “political declaration” outlining the aspirations for the future relationship between the UK and the EU after Brexit, together with the much larger withdrawal deal. The life sciences industry will be disappointed that in the drug regulatory area the political declaration contains little beyond an aspiration for “possible” cooperation between the UK drug regulator and the European Medicines Agency.
The draft political declaration on the future UK-EU relationship contains little for those in the life sciences sector seeking reassurance that the UK and EU drug regulatory systems will remain as closely aligned as possible after Brexit.
The 26-page document was endorsed by EU leaders on Nov. 25, together with the 585-page withdrawal treaty. It states that...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
