The European Parliament will vote on the European Commission’s proposals to increase cooperation on health technology assessments on Oct. 3. However, patient groups warn that amendments to the original text risk weakening the voice of the patient in the HTA debate.
Members of the European Parliament must ensure that amendments to the European Commission’s proposed regulation on EU cooperation on health technology assessments do not downgrade patient participation or create unnecessary bureaucracy that hinder clinical assessments, says Eurordis, the network representing 812 rare disease patient organizations.
The commission published its legislative proposals earlier this year in a bid to cut duplication of HTA work and avoid...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
