Two new pieces of guidance, from the EMA and the HTA coordination group respectively, should help companies understand which drugs must undergo an EU-wide joint clinical assessment and how to notify the relevant authorities about them.
The European Medicines Agency has updated its procedural guidance for developers that need to declare that their products will be subject to forthcoming EU-level joint clinical assessments (JCAs), including advice on ensuring that the pre-submission phase for both JCAs and marketing authorization applications (MAAs) can begin at the same time.
Meanwhile, the EU's Member State Coordination Group on Health Technology Assessment (HTACG) has published a guide to help developers identify...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
