Giving the UK regulator the power to approve new drugs for the whole of the UK rather than just Great Britain will simplify matters, but companies will have to consider making some changes to their product packs before the new legislation kicks in.
The European Medicines Agency has published guidance on some of the changes that pharmaceutical companies will need to make before new legislation is implemented next year allowing the UK regulator, the MHRA, to grant UK-wide approvals to products that fall within the scope of the EU centralized procedure.
At present, EU centralized approvals are valid in Northern Ireland, with MHRA approvals of such products being valid only in...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
