The European Medicines Agency’s multinational approach to drug assessment under which new marketing authorization applications are evaluated by teams formed according to expertise rather than by country has proved popular and is now being expanded to the “complex” post-authorization phase. The multinational assessment team (MNAT) concept will be broadened in phases, starting in April. Issues relating to sustainability, knowledge transfer and payment of fees to participating national authorities all have to be considered.
The European Medicines Agency is taking a step-by-step approach to expanding an initiative that for the past four years has enabled national authorities to participate in the initial assessment of new medicines through the involvement of single experts rather than via an entire team.
Until now, the initiative has applied only to procedures under the pre-authorization phase. Starting in April, the agency is expanding...
<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.
