“Incomprehensible” is how the industry group Medaxes describes a new annual tax that Belgium plans to impose on companies to address the costs arising from shortages of medicines.
A new annual tax that Belgium plans to start imposing on pharmaceutical companies to compensate for the costs arising from shortages of medicines that must then be replaced by more costly alternatives is unfair and could make the shortages problem even worse, says a Belgian industry group.
The new so-called "unavailability contribution,” which companies will have to pay based on their marketing authorizations (MAs) and parallel import...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
