EFPIA says that the European Medicines Agency’s fast-track regulatory review mechanism can be perceived by sponsors as being “hard to get and easy to lose.”
European pharmaceutical industry federation EFPIA says it would like to see enhancements made to the accelerated assessment procedure that the European Medicines Agency uses to speed up its review of EU marketing authorization applications (MAAs) for certain drugs.
The fast-track status can be perceived by sponsors as being “hard to get and easy to lose” and maintaining it...
<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.
