The European Parliament’s ENVI committee wants to help the European Council to progress with its work on the European Commission’s proposals on HTA cooperation by assuaging concerns of the EU member states.
The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee next week begins the work of discussing compromises on its draft report on the European Commission’s proposals on cooperation on health technology assessment (HTA). Among its main aims is to placate the EU member states that have strong concerns over the proposals.
Amendments clarifying what the proposed mandatory joint clinical assessments really mean and support from the Austrian EU presidency could give...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
