The European Medicines Agency will hold submission readiness meetings with the sponsors of products in the priority medicines scheme around a year ahead of them submitting their marketing authorization applications for regulatory review.
The European Medicines Agency is implementing improvements to its PRIME (priority medicines) scheme – introducing a regulatory roadmap and product development tracker, providing expedited scientific advice, and holding submission readiness meetings to help avoid the submission of premature marketing applications.
PRIME was launched in 2016 to help speed up the development and regulatory review of medicines for unmet medical needs...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
