Protection of IP and trade secrets and the need for clarity around issues such as the rules on access to data and the sharing of clinical trial data are seen as key issues in the European Commission’s plans for a European Health Data Space.
The European pharmaceutical industry body EFPIA has welcomed the EU’s proposal to establish a European Health Data Space (EHDS), saying that it offers an “unprecedented opportunity to shape the future health data and digital ecosystem” and could pave the way to more personalized health care.
However, EFPIA has some reservations about the proposal. It says, for instance, that it must give clearer assurances on the...
<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>
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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
