A six-month pilot has been launched in the EU to test new processes for multilingual packaging that allows the use of a reduced text on a medicine’s immediate and outer packaging, subject to agreement by member states.
A new pilot to improve medicines availability in smaller EU member states is exploring the feasibility of implementing a coordinated approach for preparing and evaluating multilingual packaging for drugs evaluated under the mutual-recognition and decentralized procedures (MRP/DCP).
The pilot, launched by Europe’s Heads of Medicines Agencies’ Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh),...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
