A range of steps have been taken to allow the scale-up of manufacturing of COVID-19 products during the pandemic. Now industry says the use of these flexibilities needs to be expanded to enhance the current pandemic response and rapidly increase product supply.
A group of national and international bodies representing R&D-based and generic/biosimilar companies has proposed a range of regulatory flexibilities that it says should be applied more broadly by global regulators in order to expand manufacturing capacity for COVID-19 medicines and vaccines.
The flexibilities include more streamlined stability testing requirements and greater use of harmonized approaches to alternative inspection procedures such as...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
