The UK seemingly has no intention of imposing new regulatory requirements on life science companies after the country leaves the EU. That’s all well and good, but companies in the UK looking to continue doing business in the EU are worried they will face significant trade barriers post-Brexit. Everything will depend on the outcome of soon-to-start exit negotiations.
The UK’s top medicines regulator has sought to allay some of the pharmaceutical industry’s concerns over the likely regulatory environment in the country post-Brexit. The UK will not be seeking to impose additional regulatory demands on life science companies after it leaves the EU, said Medicines and Healthcare Products Regulatory Agency chief executive Ian Hudson.
Life sciences is “a very important sector for the UK”, but it accounts for no more than around 3% of...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
