Once a major source of parallel exports because of its low drug prices, Italy is now taking steps to reduce medicine spending by targeting the burgeoning parallel import market.
The Italian regulatory agency, AIFA, has launched a new, more streamlined price negotiation mechanism for parallel imported medicines that is intended to help rein in the drugs bill by pushing down prices and implementing a “drastic reduction” in reimbursement decision times.
AIFA, which is responsible for drug pricing as well as regulatory matters, says that “transparent” criteria have been established for...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
