The aim of the pilot project is to demonstrate that an electronic package leaflet has no negative effects on the proper use of medicinal products in a hospital setting, says the industry body VIG.
VIG, the Dutch innovative medicines association, plans to run a pilot on replacing paper pack information leaflets (PILs) for hospital medicines with electronic versions. However, permission for a derogation from an EU Directive must first be granted.
In late June, the then minister for medical care, Pia Dijkstra, wrote to the European Commission for permission to run...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
