A parliamentary committee says the proposals will remove the fragmentation in the EU SPC system and bring predictability for both the innovative and generics industry.
A more harmonized, predictable and less costly EU-wide system for obtaining supplementary protection certificates (SPCs) for medicines has moved a step closer after the European Parliament’s legal affairs committee (JURI) unanimously backed two draft EU regulations that will now be voted on by the full parliament.
One of the regulations would allow applicants to obtain an SPC in designated EU member states by filing a centralized...
<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.
