Members of the European Parliament committee charged with leading the negotiations on the review of the EU pharmaceutical legislation have been presented with a study backing cuts in data protection and wider joint procurement of medicines outside emergency situations.
A controversial study that proposes reductions in the duration of regulatory data protection (RDP) and market exclusivity periods in the EU, together with the introduction of new kinds of incentives for innovation, has been formally presented to the European Parliament’s environment and public health committee (ENVI).
The study, which was prematurely published in October and then quickly withdrawn, was prepared by the parliament’s Panel for the...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.
