While Swiss new drug review procedures generally took longer last year than in 2022, there was a “substantial” reduction in review times for products submitted under Project Orbis, this year’s benchmarking study has found.
Switzerland saw drug approval procedures lengthen in 2023 compared with the previous year, with review times rising by 15% for products containing a new active substance (NAS) submitted under the standard procedure, according to the country’s medicines regulator, Swissmedic.
For all procedure types combined, Swissmedic’s reviews of NAS-containing drugs were 11% longer than those of the European Medicines Agency...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
