The joint action on ensuring security of medicines supply will be supported by the EU regulators’ shortages task force, which is to track efforts to coordinate member state activities on the supply and availability of medicines.
A joint initiative funded by the EU to coordinate and harmonize member states’ efforts to address drug shortages is expected to start by the end of this year, according to the European Medicines Agency.
The “Joint Action on Shortages” is “a three-year plan, starting at the end of 2022, that aims to help national...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
