As well as planning action to improve the EU’s competitiveness in the life science sector, the European Commission has confirmed that it will propose new legislation to reduce the bloc’s reliance on overseas suppliers of medicines as a way of tackling drug shortages.
The EU is planning to establish a new Biotech Act as part of a life sciences strategy that will help to boost European competitiveness in this sector, according to a set of “political guidelines” presented on 18 July by Ursula von der Leyen, the newly re-elected president of the European Commission.
Von der Leyen also confirmed that the commission will next year propose a “Critical Medicines Act” as part of the...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
