EU pharma companies see manufacturing and logistics issues as the main cause for supply problems, but are concerned about the costs of investing in and gaining regulatory approval for new or updated production facilities, according to a new report.
The EU needs a “robust signaling system” that can accurately detect and mitigate vulnerabilities in the supply chains for “critical” medicines using a risk-based approach with harmonized definitions and quality standards, says a new report from the European Commission’s Health Emergency Preparedness and Response Authority (HERA).
Marketing authorization holders (MAHs) see manufacturing and logistical issues as the main reasons for supply chain discontinuities, notably the complexity...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
