New guidance from the MHRA covers the issuing of UK-wide approvals for all medicines from 2025, the conversion of Great Britain product licences to UK licences, and issues relating to the approval of generics and the use of reference and comparator products.
The UK Medicines and Healthcare products Regulatory Agency has issued new guidance for anyone who may, quite reasonably, be uncertain about what happens in 2025 when yet more post-Brexit rules on the issuing of marketing authorizations come into effect.
Among the issues addressed in the guidance are the UK’s ability to approve EU centrally authorized products (CAPs) in addition...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
