The European Commission has dismissed concerns about the operation of its new emergency response body, saying it will ensure the EU is well prepared for tackling future pandemics and other threats. HERA will complement, not duplicate, work conducted by existing agencies such as the European Medicines Agency, delegates heard at this week’s European Health Forum Gastein virtual conference.
The European Health Emergency preparedness and Response Authority (HERA) will be officially established on 1 October, tasked with making sure the EU is prepared for future health emergencies, with a particular focus on the development, availability and affordability of medical countermeasures such as vaccines and therapeutics.
HERA, which will have €6bn ($7bn) in funding over the next six years, will “ensure a solid framework for EU...
<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.
