Industry and agency speakers at the DIA Europe 2022 conference voiced a litany of complaints about the EU’s drug regulatory framework, saying it has failed to keep up with developments in science and that too much assessment work is being duplicated.
The European medicines regulatory system has become too complex, there are too many decision-makers with overlapping responsibilities, and its design is “not quite fit” for the 21st century.
On top of that, the system suffers from resource issues at EU member state agencies that mean the European Medicines...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
