eCTD v4.0 Submission Guide: Japan PMDA Process & Global Differences
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is leading the way in adopting eCTD v4.0, with mandatory submissions set for 2026. This comprehensive guide delves into the PMDA's specific requirements, including the use of Japan-specific controlled vocabularies and submission structures. It also highlights key differences in eCTD v4.0 implementation across regions, ensuring a global perspective on regulatory compliance.
#eCTDv4 #PMDA #RegulatoryCompliance #GlobalRegulations #Pharmaceuticals #MedicalDevices
