The EU is funding a €1.1m project to help Moldova improve its regulatory capacity so that it is on the same footing as medical product regulators in the EU member states. The project builds on a 2014 “association agreement” signed between Moldova and the EU under plans to gradually integrate the south east European candidate country in the EU's internal market.
The Moldovan regulator for drugs and medical devices is receiving assistance from its counterparts in Lithuania and Poland – as part of an EU-funded twinning project – to strengthen its regulatory capabilities.
The project builds on a 2014 association agreement between the EU and Moldova, under which the two parties...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
