The EU’s legislative revision proposals include stripping down the European Medicines Agency’s committee structure, abolishing the five-yearly marketing authorization renewal requirement, and doing away with the “sunset clause” that requires a product to be launched in at least one EU country within three years of approval.
Among the many wide-ranging proposals for the overhaul of the EU medicines legislation that are due to be published at the end of this month is a radical restructuring at the European Medicines Agency that will see the number of its scientific committees reduced from six to two.
The two committees that would remain are the Committee on Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
