Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.
Some sections of the European Medicines Agency’s revised pharmacovigilance guideline on additional risk minimization measures are “overly detailed” and their implementation could result in confusion, the EU pharmaceutical industry federation EFPIA has stated in its written feedback to the agency.
The updated draft guideline (GVP Module XVI) was issued for stakeholder consultation earlier this year. It included “pages and pages”...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
