The use of the RPT is to no longer be required in any text of the European Pharmacopoeia and medicine developers will have to select a suitable in vitro test to control the pyrogenicity of their product.
The European Pharmacopoeia is abolishing the use of the traditional rabbit pyrogen test (RPT), in a move described as a major achievement for animal welfare and the advancement of modern in vitro approaches, and which will send out a strong message globally.
As of 1 July 2025, the use of the RPT will no longer be required in any text of the...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
