Updated clinical trial reporting rules and stronger participant protections are among the several changes to research in Switzerland that will apply from November, while new regulations on clinical trial transparency will apply from March 2025.
Switzerland’s Federal Council has approved changes to the Human Research Act (HRA) that will “strengthen the protection of persons participating in research” and “improve the regulatory framework for researchers,” according to the Federal Office of Public Health (FOPH).
In a 7 June statement, the FOPH explained that the majority of the changes to the HRA will apply...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
