eCTD Template Files
Ennov InSight includes ICH-compliant eCTD templates with preconfigured folder types to capture the metadata for the specific headings in the eCTD that require additional information: drug substance, drug product, excipient, clinical indication, and regional administrative information.
To ensure that you have the most current version of each listed template file on your system, refer to the New/ Updated in Version column in the table. This column contains information about the template status for each version in the Ennov InSight 7.2 branch:
— No - template was not updated
— Yes - template was updated
— New - template is new with this Ennov InSight version
— Blank - template did not exist for the release
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
|
templates\510k Template (Sep 2019).xml |
No | No | No | No | No | No |
| \templates \510k template.xml | No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
|
\templates \A4SampleTOCT emplate.docx |
No | No | No | No | No | No |
|
\templates \ASEAN ACTDNeeS.xml |
No | No | No | No | No | No |
| \templates\AU eCTD Module 1 v0.90.xml | No | No | No | No | No | No |
| \templates\AU Module 1 NeeS v2.0.xml | No | No | No | No | No | No |
| \templates\AU eCTD Module 1 v3.0.xml | No | No | No | No | No | No |
| \templates\AU Module 1 eCTD v3.1.xml | No | No | No | No | No | No |
| \templates\AU Module 1 eCTD v3.2.xml | Yes | |||||
| \templates\AUS Module 1 CTD v2.1.xml | No | No | No | No | No | No |
|
\templates\AUS Module 1 CTD- NeeS v2.0 2011.xml |
No | No | No | No | No | No |
|
\templates \Canadian eCTD Module 1 v1.0.xml |
No | No | No | No | No | No |
|
\templates \Canadian eCTD Module 1 v2.2.xml |
No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
| \templates \Canadian electronic CTA CTA-A-29May-2013.xml | No | No | No | No | No | No |
|
\templates \Canadian electronic CTA.xml |
No | No | No | No | No | No |
|
\templates \CNSampleTOCT emplate.docx |
New | No | No | No | No | |
| \templates\CH eCTD Module 1 v1.0.1.xml | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.1.xml | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.2.xml | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.3.xml | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.4.xml | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.5.xml | No | No | No | No | No | No |
| \templates\CN eCTD Module 1 v1.0.xml | Yes | No | No | No | No | No |
| \templates\CN eCTD ICH Module 2-5 v3.2.xml | Yes | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
|
\templates\CN Clinical Study Report (VV5-0).xml |
Yes | No | No | No | No | No |
|
\templates\CN Nonclinical Study Report (SEND Dataset).xml |
No | No | No | No | No | No |
|
\templates\CN Nonclinical Study Report.xml |
No | No | No | No | No | No |
|
\templates \eCTD ICH Module 2-5 v3.2.xml |
No | No | No | No | No | No |
| \templates \EAEU Template v1.0.xml | No | No | No | No | No | No |
|
\templates\EU CTA.xml |
No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.0 - CP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.0 - MRPDCP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.0 - NP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.1 - CP.xml | No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
| \templates\EU eCTD Module 1 v1.1 - MRPDCP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.1 - NP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.2.1 - CP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.2.1 - MRPDCP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.2.1 - NP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.3 - CP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.3 - MRPDCP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.3 - NP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.4 - CP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.4 - MRPDCP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.4 - NP.xml | No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
| \templates\EU eCTD Module 1 v2.0 - CP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v2.0 - MRPDCP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v2.0 - NP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0 - CP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0 - MRPDCP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0 - NP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.1 - CP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.1 - MRPDCP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.1 - NP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.3 - CP.xml | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.3 - MRPDCP.xml | No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
| \templates\EU eCTD Module 1 v3.0.3 - NP.xml | No | No | No | No | No | No |
|
\templates\EU \EU eCTD Module 1 v3.1 CP.xml |
New | |||||
|
\templates\EU \EU eCTD Module 1 v3.1 NP.xml |
New | |||||
|
\templates\EU \EU eCTD Module 1 v3.1 - MRP-DCP.xml |
New | |||||
|
\templates\EU IMPD template.xml |
No | No | No | No | No | No |
| \templates\EU PMF Submission in eCTD.xml | No | No | No | No | No | No |
|
\templates\EU VNeeS - Immunological.x ml |
No | No | No | No | No | No |
|
\templates\EU VNeeS - Pharmaceutical. xml |
No | No | No | No | No | No |
|
\templates\EU VNeeS v2.2 Immunological.x ml |
No | No | No | No | No | No |
|
\templates\EU VNeeS v2.2 MRL Maximum Residue Limits.xml |
No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
|
\templates\EU VNeeS v2.2Pharmaceutical. xml |
No | No | No | No | No | No |
|
\templates\EU VNeeS v2.3 Immunological.xml |
No | No | No | No | No | No |
|
\templates\EU VNeeS v2.3 MRL Maximum Residue Limits.xml |
No | No | No | No | No | No |
|
\templates\EU VNeeS v2.3Pharmaceutical.xml |
No | No | No | No | No | No |
| \templates\GCC eCTD Module 1 v1.2 - GCC.xml | No | No | No | No | No | No |
| \templates\GCC eCTD Module 1 v1.2 - NP.xml | No | No | No | No | No | No |
| \templates\GCC eCTD Module 1 v1.5 - GCC.xml | No | No | No | No | No | No |
| \templates\GCC eCTD Module 1 v1.5 - NP.xml | No | No | No | No | No | No |
| \templates\HR eCTD Module 1 v1.4 - NP.xml | No | No | No | No | No | No |
|
\templates\ICH E3 Clinical Study Report (VV2-2).xml |
No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
|
\templates\ICH E3 Clinical Study Report (VV3-0).xml |
No | No | No | No | No | No |
|
\templates\ICH E3 Clinical Study Report (VV5-0).xml |
No | No | No | No | No | No |
| \templates\JO eCTD Module 1 v1.0.xml | No | No | No | No | No | No |
| \templates\JO eCTD Module 1 v1.1.xml | No | No | No | No | No | No |
| \templates\JP eCTD Module 1 v1.0.xml | No | No | No | No | No | No |
| \templates\JP eCTD Module 2-5 v3.2.xml | No | No | No | No | No | No |
|
\templates \JPSampleTOCT emplate.docx |
N/A | New | No | No | No | No |
|
\templates\MD - IMDRF (HC) IVD Template.xml |
No | No | No | No | No | No |
|
\templates\MD - IMDRF nIVD Template.xml |
No | No | No | No | No | No |
|
\templates \Nonclinical Study Report (SEND Dataset).xml |
No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
|
\templates \Nonclinical Study Report.xml |
No | No | No | No | No | No |
|
\templates\PMA Template (Feb 2019).xml |
No | No | No | No | No | No |
|
\templates\PMA Template.xml |
No | No | No | No | No | No |
|
\templates\ROW CTD Module 1.xml |
No | No | No | No | No | No |
| \templates \SampleCoverPa geTemplate.doc x | No | No | No | No | No | No |
|
\templates \SampleOverlay Template.docx |
No | No | No | No | No | No |
|
\templates \SampleTOCTe mplate.docx |
No | No | No | No | No | No |
|
\templates \Saudi Arabia CTD Module 1 v1.0.xml |
No | No | No | No | No | No |
| \templates\TH eCTD Module 1 v0.92.xml | No | No | No | No | No | No |
| \templates\TH eCTD Module 1 v1.0.xml | No | No | No | No | No | No |
| \templates\TW eCTD Module 1 v1.0.xml | No | No | No | No | No | No |
| Template | New/Updated in Version | |||||
| 7.1.1 | 7.2.10 | 7.2.11 | 7.2.12 | 7.2.13 | 7.2.14 | |
| \templates\UA eCTDModule 1 v1.0 | New | |||||
| \templates \UCSampleCove rPageTemplate. docx | No | No | No | No | No | No |
| \templates \UCSampleOverl ayTemplate.doc x | No | No | No | No | No | No |
| \templates\US eCTD Module 1 v2.01.xml | No | No | No | No | No | No |
| \templates\US eCTD Module 1 v3.3.xml | No | No | No | No | No | No |
|
\templates \WHO eCTD Module 1 v1.0 |
New | |||||
| \templates\ZA eCTD Module 1 v1.0.xml | No | No | No | No | No | No |
| \templates\ZA eCTD Module 1 v2.1.xml | No | No | No | No | No | No |
| \templates\ZA eCTD Module 1 v3.0.xml | N/A | New | Deleted | No | No | No |
| \templates\ZA eCTD Module 1 v3.1.xml | N/A | N/A | New | No | No | No |