Legislation intended to remove the fragmentation in the supplementary protection certificate system has been OKd by the European Parliament, which will try to reach agreement with the EU member states following the June parliamentary elections.
New EU rules on extending the effective patent life of medicinal products drew nearer today after the European Parliament voted through two draft regulations that aim to make it easier to seek supplementary protection certificates (SPCs) with effect in all EU member states.
One of the regulations would allow companies to apply for an SPC in specified countries by filing a centralized application,...
<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.
