The Swiss drug regulator makes public the indications in drug marketing applications within 60 days of receiving them, but says the level of detail that companies provide on this front is inconsistent. It also promises to be more stringent when it comes to assessing claims by companies who are worried that their commercially confidential information will be disclosed.
Switzerland’s drug regulator, Swissmedic, has clarified how it wants companies to describe drug indications in their marketing applications, after finding that the level of detail in the information submitted “varies greatly” and is “insufficient in some cases.”
In addition, it has pledged to more stringently assess the validity of claims by companies that publication of their proposed...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
