One of the many consequences of Brexit is that medicines for marketing across the UK will have to carry the words “UK Only,” which will involve companies having to notify the regulator of changes to their product artwork.
The UK government has issued guidance explaining the new labeling requirements for medicines that are licensed on a UK-wide basis as of 1 January 2025, noting that companies wanting to comply with the rules before that date are welcome to do so.
The key requirements for medicines under the so-called “Windsor Framework” agreed by the UK and the EU in February is...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
