The European Commission is mulling the addition of an opt-out mechanism for patients under its European Health Data Space framework, but health and pharma industry stakeholders have warned that this could cause “scientific damage” and act as a barrier to research.
A main aim of the European Commission’s proposed European Health Data Space (EHDS) is to enable the secondary use of anonymized, or pseudo-anonymized, patient health data for purposes such as scientific research and health policy development.
This initiative, which would be introduced under an EU-wide regulation, has been broadly welcomed by industry, academic groups and healthcare...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
