From next year, more agencies will be involved in the UK’s regulatory reliance procedure for new drug approvals, which was first introduced in 2021 to allay fears of post-Brexit delays to UK applications. The pharmaceutical industry said it looked forward to working with the regulator on the new framework.
The UK Medicines and Healthcare products Regulatory Agency has confirmed that it will implement a new international framework in January 2024 under which it will be able to take account of decisions by other world regulators when evaluating new drugs submitted for marketing authorization.
“Our aim is to extend the countries whose assessments we will take account of, increasing routes to market in 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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
