Giving the UK regulator the power to issue UK-wide marketing authorizations for products that fall within the scope of the EU centralized procedure will reduce the regulatory burden on companies marketing medicines in Northern Ireland.
New rules under which all novel medicines could receive UK-wide approval from the Medicines and Healthcare products Regulatory Agency drew nearer today after the European Parliament endorsed a draft regulation ending the validity of EU marketing authorizations in Northern Ireland.
The regulation is one of three draft laws implementing the Windsor Framework, a deal that was agreed in February by...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
