With proposals for an overhaul of the EU medicines legislation due at the end of this year, EFPIA has published its formal response to the European Commission’s consultation with suggestions for facilitating new antibiotic development, testing new regulatory approaches to novel medicines, and tackling medicine shortages.
The European pharmaceutical industry federation EFPIA has called for the introduction of a “transferable exclusivity extension” as an incentive to encourage companies to invest in the development of new products to tackle antimicrobial resistance (AMR), which it says could easily be implemented via EU legislation.
EFPIA is also in favor of a centralized mechanism for deciding whether promising novel treatments for various diseases should be...
<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.
