The EMA is proposing to update its two previous guidelines on COVID-19 vaccines to offer consolidated advice on the non-clinical and clinical development of new SARS-CoV-2 or related sarbecovirus vaccines.
The European Medicines Agency is inviting stakeholder feedback on a proposal to update and consolidate its two guidelines on regulatory requirements for COVID-19 vaccines, taking into account new scientific knowledge and lessons learnt from the coronavirus pandemic.
The EMA said changes were needed as the “vaccine development landscape is now very different to that applicable when the...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
