A senior German regulator says that changes the EU medicines regulatory network has been making since the UK announced it was leaving the EU means that nothing will ever be the same again irrespective of whether the UK is allowed to remain in network as part of a Brexit deal.
While discussions continue over whether the UK can continue to participate in the EU medicines network following Brexit, one German regulator feels that aspects relating to the regulatory network have already changed so much that "we have reached the point of no return."
"It doesn't matter if the UK say that they are staying in the [EU regulatory] system or not,” said Peter...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
