New guidance from the European Medicines Agency is calling on supply chain participants to be more proactive in forecasting and notifying medicine shortages, while a group of EU member states has said that “more drastic steps” need to be taken to improve the security of medicines supply.
Pharmaceutical companies, manufacturers and wholesalers should have a prevention plan for identifying supply chain weaknesses and potential drug shortages as well as shortages management plan that determines how a company reacts once a supply issue has been identified, according to new “best practice” guidance from the European Medicines Agency.
Companies are also urged to “increase the accuracy” of the detail in their shortage notifications and to report potential or...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
