A report commissioned by the European pharmaceutical industry body EFPIA has come up with some suggestions for reducing the time the European Commission takes to issue marketing authorizations for cancer drugs – and possibly other products too.
The European R&D-based industry is looking to capitalize on the fact that regulators have shown great flexibility during the coronavirus pandemic and approved vaccines and drugs in record times.
The coronavirus pandemic has shown that it is possible to accelerate the scientific review of vaccines and therapeutics for COVID-19...
<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.
