A new EU regulation has come into effect, giving the European Medicines Agency wider powers to monitor, prevent and manage shortages of medicines and medical devices in public health emergencies. A number of steering groups and other bodies and networks are being set up to put the new systems into action.
The next couple of months will see a flurry of activity at the European Medicines Agency as it sets up a number of new bodies to monitor and tackle potential or actual shortages of critical medicines and medical devices in public health crisis situations.
A new Executive Steering Group on Shortages and Safety of Medicinal Products will be set up and hold its first...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
