The EU’s new health commissioner, Stella Kyriakides, has outlined the commission’s plans for dealing with medicines access issues in the EU member states. They include completing the review of the EU pediatric and orphan legislation and developing a new strategic plan to tackle shortages and affordability problems next year.
The European Commission is working on a new plan for tackling the problem of medicines shortages and affordability, which should be ready by the end of 2020.
The plan will take account of the review of the EU pediatric and orphan legislation, which is expected to be...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
