The new regulatory framework in the Eurasian Economic Union is now in place and the first drug approval applications have been filed under the mutual recognition system. Applications are expected to rise significantly in 2019 once IT systems are fully in place and more experience has been gained.
About 20 marketing authorization (MA) applications have so far been submitted under the new five-country Eurasian single regulatory framework for medicines, and the first approvals are expected to be granted by the end of 2018 or the beginning of 2019.
It appears that no applications have been accepted by the Russian authorities, even though the applications were submitted with payment...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
