The European Commission’s plans for overhauling the EU medicines legislation have elicited a number of proposals from the pharmaceutical industry to improve the regulatory framework, including streamlining the committee system, improving the use of expedited evaluation pathways, and expanding the European Medicines Agency’s role in assessing drug/device combination products.
The EU’s regulatory framework is “complex, slow and administratively burdensome,” and the European Medicines Agency’s committee structure and network operating model are “reaching their limits” in terms of speedy, high-quality assessments.
More expertise is needed to assess highly innovative medicines, but this may not be available in the EU network and...
<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.
