Power Viewer supports both ICH eCTD v3.2.2 and v4.0.
The regulatory region is auto-detected by reading the OID values and region-specific XML filenames in submissionunit.xml or index.xml.
v4.0 support
Agency, Region
Supported ID versions
ICH
v1.6 / v1.4
MHLW/PMDA, Japan
v1.6 / v1.4
FDA, United States
v1.8 / v1.5
EMA, Europe
v1.0
v3.2.2 support
Agency, Region
MHLW/PMDA, Japan
FDA, United States
EMA, Europe
Swissmedic, Switzerland
Health Canada
TGA, Therapeutic Goods Administration
NMPA, National Medical Products Administration
TFDA, Taiwan Food and Drug Administration
Health Sciences Authority
FDA Thailand
MFDS
SAHPRA
How Agency Specifications Are Identified
Power Viewer reads the XML to automatically detect which agency’s eCTD specification is being used.
Power Viewer