The assumption to date has been that the European Medicines Agency will have to move from its London base when the UK leaves the EU. But things may not be quite that simple.
UK prime minister Theresa May has said that the formal negotiation process that will lead to the UK leaving the EU will begin by the end of March 2017, meaning the country could be out of the trading bloc by April 2019. One of the many unknowns with regard to Brexit is just how the European Medicine Agency’s new home will be chosen – if indeed the agency has to move from London.
The EU treaties do not formally state that EU agencies must be located in an EU member state, but the...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
