An injection of new money should provide something of a shot in the arm for the UK’s drugs regulator as it deals with post-Brexit realities.
New funding announced yesterday for the UK Medicines and Healthcare products Regulatory Agency will be used to develop a “thorough but shortened process” to speed up the approval of innovative UK-developed products such as cancer vaccines and AI-based therapeutics for mental health conditions.
Some of the £10m ($12m) allotted to the MHRA in chancellor Jeremy Hunt’s spring budget yesterday will also be used...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
