The European Council’s draft guidelines on the future UK-EU relationship say that the UK, as a third country outside the EU single market, will not be able to participate in any EU agencies after Brexit, dashing hopes expressed by the government that the UK could have “associate membership” of the EMA. However, the UK BioIndustry Association remains optimistic that some form of regulatory cooperation can be negotiated in the interests of all stakeholders.
The European Council says that the UK will not be able to take part in any EU agencies after Brexit, directly contradicting suggestions by prime minister Theresa May last week that the UK could seek “associate membership” of the European Medicines Agency after March 2019.
The statement is contained in the draft guidelines drawn up by the council on the future relationship between the UK...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
