Ambitious efforts to make the EU more resilient to future challenges, such as health threats, drug supply problems, scientific advances and growing medicine costs, have taken a step forward with the publication of a roadmap for a wide-ranging Pharmaceutical Strategy to be adopted by the European Commission later in the year.
The European Commission has unveiled a set of proposals for overhauling the EU drug regulatory framework in order to ensure timely patient access to affordable medicines, support the development of innovative medicines that meet patients’ needs, and tackle the root causes of drug shortages.
In a “roadmap” outlining a future Pharmaceutical Strategy, the commission says that innovative therapies do not reach all patients...
<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.
