The EMA has published its analysis of the 19 bids to host the agency post-Brexit, which confirms reports that five cities – Amsterdam, Barcelona, Copenhagen, Milan and Vienna – would bring the best result in terms of retaining staff when it relocates. The agency has expressed concern that low retention rates could hit operations and result in lower fee income, requiring an injection of cash from the EU budget.
The European Medicines Agency’s management board has begun discussing the budgetary implications of its forced relocation from London as a result of Brexit, on the assumption that expected staff losses could impair the agency’s ability to operate properly, leading to a “dramatic” drop in fee income and a major shortfall in its budget.
A significant fall in income from industry fees would in turn result in reduced payments to the national competent authorities...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
