Proposals for establishing a ‘European Health Union’ include measures to give the EU regulator more say in monitoring and mitigating potential and actual shortages of drugs and devices in the event of serious public health crises.
The Council of the EU has approved a draft regulation that would confer more powers on the European Medicines Agency to tackle medicine shortages in the event of pandemics and other health emergencies.
On 15 June the council, representing EU member state health ministers, adopted a “general approach” that gives the presidency of...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
