This year’s new fee structure at the EMA takes account of the inflation rates in 2020 and 2021 and includes changes relating to inspections and companion diagnostics.
The European Medicines Agency has published the new fees it is charging industry for services relating to human and veterinary medicines as of 1 April. The full fee for a marketing authorization application (MAA) for a human-use medicine, for example, has increased by just under 7%, to €313,200 ($342,000) from €296,500.
A number of changes have been made to the fee structure, including clarification on the fee charged when an inspection...
<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.
