Here is the support status for each eCTD Version and Region.
TOC
v4.0
Supports eCTDs defined in the IGs of the following Versions.
eCTDs compliant with the IGs of PMDA, EMA, and FDA are treated as the respective authority’s specifications. eCTDs that follow ICH specifications but do not fall under these authorities are treated as eCTDs for other regions.
ICH
| IG Version | Supported Power Viewer Version | OID |
|---|---|---|
| 1.6 | v1.0.0 or later | 2.16.840.1.113883.3.989.2.2.1.11.5 |
| ~ | ||
| 1.4 | v1.0.0 or later | 2.16.840.1.113883.3.989.2.2.1.11.3 |
MHLW/PMDA, Japan
| IG Version | Supported Power Viewer Version | OID |
|---|---|---|
| 1.6 | v1.0.0 or later | 2.16.840.1.113883.3.989.5.1.3.3.1.16.5 |
| ~ | ||
| 1.4 | v1.0.0 or later | 2.16.840.1.113883.3.989.5.1.3.3.1.16.3 |
FDA, United States
| IG Version | Supported Power Viewer Version | OID |
|---|---|---|
| 1.8 | v1.0.0 or later | 2.16.840.1.113883.3.989.5.1.2.2.1.18.6 |
| ~ | ||
| 1.5 | v1.0.0 or later | 2.16.840.1.113883.3.989.5.1.2.2.1.18.6 |
EMA, Europe
| IG Version | Supported Power Viewer Version | OID |
|---|---|---|
| 1.0 | v2.0.4 | 2.16.840.1.113883.3.989.5.1.1.6.1.1 |
v3.2.2
The corresponding Power Viewer version is listed for each region.
| Region | Supported Power Viewer Version |
|---|---|
| MHLW/PMDA, Japan | v1.0.0 and later |
| FDA, United States | v1.0.0 and later |
| EMA, Europe | v1.2.0 and later |
| Swissmedic, Switzerland | v2.0.4 and later |
| Health Canada | v2.1.2 and later |
| TGA, Therapeutic Goods Administratio | v2.1.2 and later |
| NMPA, National Medical Products Administration | v2.1.2 and later |
| TFDA, Taiwan Food and Drug Administration | v2.1.2 and later |
| Health Sciences Authority | v2.1.2 and later |
Identification
Power Viewer references the xml to identify which agency’s eCTD specifications are being used.
| xml | Regional IG/Regional XML | Identification |
|---|---|---|
| submissionunit.xml | 2.16.840.1.113883.3.989.5.1.3.3.1.16.x | v4.0/JP |
| submissionunit.xml | 2.16.840.1.113883.3.989.5.1.2.2.1.18.x | v4.0/US |
| submissionunit.xml | 2.16.840.1.113883.3.989.5.1.1.6.1.x | v4.0/EU |
| submissionunit.xml | Other than the above | v4.0/Other |
| index.xml | jp-regional-index.xml | v3.2.2/JP |
| index.xml | us-regional.xml | v3.2.2/US |
| index.xml | eu-regional.xml | v3.2.2/EU |
| index.xml | ch-regional.xml | v3.2.2/CH |
| index.xml | au-regional.xml | v3.2.2/AU |
| index.xml | ca-regional.xml | v3.2.2/CA |
| index.xml | cn-regional.xml | v3.2.2/CN |
| index.xml | sg-regional.xml | v3.2.2/SG |
| index.xml | tw-regional.xml | v3.2.2/TW |
| index.xml | Other than the above | Not recognized as eCTD |