The criteria that candidates seeking to host the European Medicines Agency post-Brexit will have to meet are out for discussion among member state representatives and should be finalized towards the end of June. Formal bids will have to be in by July end and a decision on the EMA’s new home should be made in October.
EU member state representatives are about to begin examining the criteria that candidate countries will have to meet if they want to host the European Medicines Agency when it leaves London as a result of Brexit. Member states will have until the end of July to submit a formal bid. The final decision on the new home for the agency is still expected to be taken in October.
Among the criteria will be the ability of the host city to provide good flight connections to other cities as...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
