The UK medicines regulator is mulling the possibility of drawing on its existing international regulatory partnerships, such as the ACCESS Consortium, to tackle challenges in its clinical trials sector, and says sponsors can expect greater support early in the trial process.
The UK’s clinical trial landscape has begun to recover from post-Brexit problems including delays in the review of applications from sponsors and dwindling numbers of studies, prompting the Medicines and Healthcare products Regulatory Agency to consider options for avoiding similar disruptions in the future.
“We know that clinical trials have been through a difficult period. But I'm very pleased to say that we are...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
