The late delivery of the “pharmaceutical package” leaves little time for the legislative process to take shape before European Parliament elections are held in June next year.
The European Commission’s ambitious – not to say contentious – package of proposals for revising the EU pharmaceutical legislation is to get its first airing on Wednesday when it is due to be presented to a European Parliament committee for an “exchange of views.”
There will be a short presentation by the commission on the main points of the proposals, and “a couple 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>
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.
