EU member states told the latest meeting of a European Commission advisory committee about steps they have taken to deal with drug shortages, including export bans, prescribing restrictions, the establishment of “national safety stocks,” and specific requirements on marketing authorization holders.
The health authorities in the Czech Republic are to carry out a survey of measures taken by individual EU countries to tackle medicines shortages in order to determine which measures might “potentially impact security and continuity of supply” in other countries of the EU, according to the European Commission.
“The Czech Republic stressed the importance of understanding and sharing information about national and EU-level measures to prevent and mitigate...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
