National pricing and reimbursement systems remain a key barrier to medicines access, and requiring companies to market their products in all EU countries and to notify regulators of their launch intentions is not the answer, according to EuropaBio, which represents a wide range of biotech firms operating in Europe.
Efforts by the EU authorities to improve the drug regulatory environment have met with a lukewarm response from industry body EuropaBio. It says the proposed revision of the EU pharmaceutical legislation “does not align with the European Commission’s bid to promote the EU as a competitive global leader in biopharmaceutical R&D.”
EuropaBio claims that “little in this revision seeks to address the issues we face for next-generation medicine development, and errs...
<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.
