FDA, EMA officials encourage companies to pilot eCTD 4.0
Regulatory NewsJoanne S. Eglovitch
Biologics/ biosimilars/ vaccinesBiotechnologyComplianceCTD/eCTDEuropean Medicines Agency (EMA)GlobalMedicines and Healthcare products Regulatory Agency (MHRA)PharmaceuticalsRegulatory harmonizationRegulatory Intelligence/PolicyTechnical documentationUS Food and Drug Administration (FDA)