EU health authorities inspected fewer drug manufacturing facilities under Europe’s centralized procedure in 2017 thanks to last year’s US/EU mutual recognition agreement, according to a 2017 annual report from the European Medicines Agency. They also found fewer GMP problems at the facilities they did inspect.
European health authorities are conducting fewer good manufacturing practice inspections at facilities regulated under the EU’s centralized marketing procedure thanks to a recent US/EU mutual recognition agreement on drug GMP inspections, according to the European Medicines Agency’s 2017 annual report.
The report, issued on May 2, said that after an increase every year, the number of GMP inspections dropped...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
