A report by the European Medicines Agency outlines the progress that has been made so far in delivering on the key pillars of its five-year network strategy, proposed in 2020, and lists areas where work is ongoing.
Tackling medicines shortages, improving regulatory sustainability, and reducing the threat of antimicrobial resistance were among the six priority areas of a five-year plan published by the European Medicines Agency (EMA) and EU Heads of Medicines Agencies (HMA) at the end of 2020.
The European medicines agencies network strategy (EMANS) reached its halfway point this June, and according to a midterm report...
<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>
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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
