More agile regulatory processes, a much shorter period for the European Commission to make new drug approval decisions, and a firm legal basis for the European Medicines Agency in assessing combination products. These are among proposals put forward by Europe’s R&D-based pharmaceutical industry amid moves to revise the EU medicines legislation.
The European pharmaceutical industry federation EFPIA has published a report outlining a set of “clear and actionable recommendations” for improving the EU pharmaceutical legislation to “enable rapid patient access to medicines without compromising safety.”
The report, called Evidence MIX: Evaluating the EU Regulatory System, is part of EFPIA’s response to the European Commission’s Pharmaceutical...
<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.
