About 10% of marketed medicines chosen at random in Denmark had “non-functioning” anti-tamper devices, leaving them open to possible interference.
The Danish Medicines Agency (DKMA) is working on a project to check anti-tamper devices (ATDs) on medicine packs after about a tenth of selected marketed products were found to have an ATD that could be removed without leaving any evidence that the pack had been opened or otherwise interfered with.
Under the EU’s Falsified Medicines Directive, ATDs such as tapes and stickers must be placed across the opening of prescription...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
