Industry officials: Varied global postapproval change requirement pose challenges for drugmakers
Regulatory NewsJoanne S. Eglovitch
Audit/inspectionBiologics/ biosimilars/ vaccinesBiotechnologyChemistry, Manufacturing and Controls (CMC)ComplianceGlobalGMPICHICMRAPharmaceuticalsPIC/SPostmarketing requirement/postmarketing commitmentProduct LifecycleQuality Assurance and ControlRegulatory harmonizationRegulatory Intelligence/PolicyShortagesWHO