The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.
The European Union (EU) reform establishes a regulatory data and market protection period of eight years, capped at 11 years ...
The CNPV pilot program approved its first drug, an amoxicillin-clavulanate potassium antibiotic, in two months, enhancing domestic manufacturing and national security. Augmentin XR, combining ...