As part of post-Brexit arrangements to make sure new drugs are made available to people in all four countries of the UK, an interim mechanism has been set up for when a product is approved in the UK before the EU.
The UK has implemented a mechanism to ensure that new medicines falling under the scope of the EU centralized approvals procedure are made available to patients across the UK until new rules giving the UK regulator the power to issue UK-wide marketing authorizations for such products take effect in 2025.
At present, marketing authorizations (MAs) for new medicines issued by the European Commission (EC) are valid in Northern Ireland under...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
