EMA To Coordinate GMP Inspections Via Online Portal
Executive Summary
The EMA hopes that the use of a single portal by drug companies and EU/EEA inspectorates to coordinate on good manufacturing practice inspections will drive greater efficiency.
You may also be interested in...
Faster Submissions For Orphan Designation Possible As EMA’s Online Portal Goes Live
The new portal is expected to provide an improved method for applying for and managing EU orphan drug designations.
BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval
Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.
EMA Gives Oncopeptides’ Multiple Myeloma Drug The Thumbs Up; Keeps US FDA In Loop
With Pepaxti now on track for pan-EU marketing approval to treat patients with triple class refractory multiple myeloma, Oncopeptides is in talks with the Food and Drug Administration to achieve a clear path forward for the drug in the US where it has experienced difficulties despite being granted an accelerated approval.