Revisions and restructuring of the contract with the developers mean that Europe’s new clinical trials system will not go live next year as planned, although the European Medicines Agency says progress has been made with development of the system.
The implementation of the EU Clinical Trial Regulation (CTR) will be delayed again after it was announced that the audit of the planned Clinical Trials Information System will not now begin until the end of 2020. This suggests that the system will not be in use until more than three years after the original deadline.
If the original delivery timescales for the various stages of the audit and application process are adhered to, the delay...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
