The ESMP will have dedicated secure spaces for companies and national agencies to provide data on the supply situation for critical medicines both under normal circumstances and in crisis situations.
The European Medicines Agency’s new platform for monitoring medicine supply, demand and availability during health crisis situations is to go live for marketing authorization holders (MAHs) in November and for national regulators by the legal deadline of February 2025.
The European Shortages Monitoring Platform (ESMP) will be used in three circumstances: for routine reporting of shortages of “critical” centrally...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
