Europe’s top drugs regulator has reorganized its operations to tackle what it calls “fundamental changes” brought by new legislative initiatives, digital technologies, global trends in science, and staff losses due to Brexit. More changes are to be implemented during the course of 2020 in a bid to optimize the agency’s regulatory and scientific output.
The European Medicines Agency has implemented its new organizational structure, including a fully integrated human medicines division, a move that was first announced at the end of last year as part of a “future-proofing” exercise that the agency hopes will keep up the quality of its services to stakeholders.
Spurred by the loss of staff following its relocation to Amsterdam, as well as the need to tackle new challenges...
<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.
