Urinary Urokinase (UK) Export Faces New Compliance Barriers Under Global Regulatory Upgrade

As global pharmaceutical regulatory authorities follow up the implementation of ICH Q14, urokinase raw material exports from China are facing stricter inspection on biological impurity safety and production traceability. Domestic urokinase manufacturers are optimizing virus inactivation processes and establishing full-chain urine collection traceability systems to meet international access standards.