The European Medicines Agency has issued revised guidance on its Clinical Data Publication policy to help companies navigate procedural changes that will be introduced when the publication of clinical trial data on non-COVID-19 products is partially resumed under the policy from September 2023.
The European Medicines Agency has updated the Q&A document on how companies should go about identifying, redacting, anonymizing and submitting clinical trial documents ahead of the phased re-start of its landmark transparency policy in September.
The Q&As have been revised to clarify the scope of the Clinical Data Publication (CDP) policy, and address procedural changes...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
