If the European Medicines Agency has to desert London as a result of the UK’s decision to leave the EU, it will have to take care in managing issues such as the loss of expert input from the UK regulator, the MHRA, says former EMA head Thomas Lönngren.
Following the decision by the UK to leave the European Union, it will be hard to tell what the future holds for the country within the European drug regulatory system and for the London-based European Medicines Agency itself until we know just what kind of relationship the UK will eventually forge with the EU and its 27 other member states.
The EMA has said that it's business as usual for the time being, and that the implications for its location...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
