Ennov InSight RIM Publisher 7.1

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 InSight7.1 branch:
  • No - template was not updated
  • Yes - template was updated
  • New - template is new with this Ennov InSight version
  • N/A - template did not exist for the release
Template New/Updated in Version
7.0 7.1 7.1.3 7.1.14 7.1.15
\templates\510k Template (Sep 2019).xml Yes No No No No
\templates\510k template.xml No No No No No
\templates\A4SampleTOCTemplate.docx No No No No No
\templates\ASEAN ACTD-NeeS.xml No No No No No
\templates\AU eCTD Module 1 v0.90.xml No No No No No
\templates\AU eCTD Module 1 v3.0.xml No No No No No
\templates\AU Module 1 eCTD v3.1.xml No No No No No
\templates\AU Module 1 NeeS v2.0.xml No No No No No
\templates\AUS Module 1 CTD v2.1.xml No No No No No
\templates\AUS Module 1 CTD-NeeS v2.0 2011.xml No No No No No
\templates\Canadian eCTD Module 1 v1.0.xml No No No No No
\templates\Canadian eCTD Module 1 v2.2.xml No No No No No
\templates\Canadian electronic CTA CTA-A-29-May-2013.xml No No No No No
\templates\Canadian electronic CTA.xml No No No No No
\templates\CH eCTD Module 1 v1.0.1.xml No No No No No
\templates\CH eCTD Module 1 v1.1.xml No No No No No
\templates\CH eCTD Module 1 v1.2.xml No No No No No
\templates\CH eCTD Module 1 v1.3.xml No No No No No
\templates\CH eCTD Module 1 v1.4.xml No No No No No
\templates\CH eCTD Module 1 v1.5.xml No No No No No
\templates\CN eCTD Module 1 v1.0.xml No No Yes No No
\templates\CN eCTD ICH Module 2-5 v3.2.xml No No Yes No No
\templates\CN Clinical Study Report (VV5-0).xml No No Yes No No
\templates\CN Nonclinical Study Report (SEND Dataset).xml No No No No No
\templates\CN Nonclinical Study Report.xml No No No No No
\templates\eCTD ICH Module 2-5 v3.2.xml No No No No No
\templates\EAEU Template v1.0.xml No No No No No
\templates\EU CTA.xml No No No No No
\templates\EU eCTD Module 1 v1.0 - CP.xml No No No No No
\templates\EU eCTD Module 1 v1.0 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v1.0 - NP.xml No No No No No
\templates\EU eCTD Module 1 v1.1 - CP.xml No No No No No
\templates\EU eCTD Module 1 v1.1 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v1.1 - NP.xml No No No No No
\templates\EU eCTD Module 1 v1.2.1 - CP.xml No No No No No
\templates\EU eCTD Module 1 v1.2.1 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v1.2.1 - NP.xml No No No No No
\templates\EU eCTD Module 1 v1.3 - CP.xml No No No No No
\templates\EU eCTD Module 1 v1.3 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v1.3 - NP.xml No No No No No
\templates\EU eCTD Module 1 v1.4 - CP.xml No No No No No
\templates\EU eCTD Module 1 v1.4 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v1.4 - NP.xml No No No No No
\templates\EU eCTD Module 1 v2.0 - CP.xml No No No No No
\templates\EU eCTD Module 1 v2.0 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v2.0 - NP.xml No No No No No
\templates\EU eCTD Module 1 v3.0 - CP.xml No No No No No
\templates\EU eCTD Module 1 v3.0 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v3.0 - NP.xml No No No No No
\templates\EU eCTD Module 1 v3.0.1 - CP.xml No No No No No
\templates\EU eCTD Module 1 v3.0.1 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v3.0.1 - NP.xml No No No No No
\templates\EU eCTD Module 1 v3.0.3 - CP.xml No No No No No
\templates\EU eCTD Module 1 v3.0.3 - MRP-DCP.xml No No No No No
\templates\EU eCTD Module 1 v3.0.3 - NP.xml No No No No No
\templates\EU eCTD Module 1 v3.1 - CP.xml New
\templates\EU eCTD Module 1 v3.1 - NP.xml New
\templates\EU eCTD Module 1 v3.1 - MRP-DCP.xml New
\templates\EU IMPD template.xml No No No No No
\templates\EU PMF Submission in eCTD.xml No No No No No
\templates\EU VNeeS - Immunological.xml No No No No No
\templates\EU VNeeS - Pharmaceutical.xml No No No No No
\templates\EU VNeeS v2.2 - Immunological.xml No No No No No
\templates\EU VNeeS v2.2 - MRL Maximum Residue Limits.xml No No No No No
\templates\EU VNeeS v2.2- Pharmaceutical.xml No No No No No
\templates\EU VNeeS v2.3 - Immunological.xml No No No No No
\templates\EU VNeeS v2.3 - MRL Maximum Residue Limits.xml No No No No No
\templates\EU VNeeS v2.3- Pharmaceutical.xml No No No No No
\templates\GCC eCTD Module 1 v1.2 - GCC.xml No No No No No
\templates\GCC eCTD Module 1 v1.2 - NP.xml No No No No No
\templates\GCC eCTD Module 1 v1.5 - GCC.xml No No No No No
\templates\GCC eCTD Module 1 v1.5 - NP.xml No No No No No
\templates\HR eCTD Module 1 v1.4 - NP.xml No No No No No
\templates\ICH E3 Clinical Study Report (VV2-2).xml No No No No No
\templates\ICH E3 Clinical Study Report (VV3-0).xml No No No No No
\templates\ICH E3 Clinical Study Report (VV5-0).xml No No No No No
\templates\JO eCTD Module 1 v1.0.xml No No No No No
\templates\JO eCTD Module 1 v1.1.xml No No No No No
\templates\JP eCTD Module 1 v1.0.xml No No No No No
\templates\JP eCTD Module 2-5 v3.2.xml No No No No No
\templates\MD - IMDRF (HC) IVD Template.xml Yes No No No No
\templates\MD - IMDRF nIVD Template.xml Yes No No No No
\templates\Nonclinical Study Report (SEND Dataset).xml No No No No No
\templates\Nonclinical Study Report.xml No No No No No
\templates\PMA Template (Feb 2019).xml Yes No No No No
\templates\PMA Template.xml No No No No No
\templates\ROW CTD Module 1.xml No No No No No
\templates\SampleCoverPageTemplate.docx No No No No No
\templates\SampleOverlayTemplate.docx No No No No No
\templates\SampleTOCTemplate.docx No No No No No
\templates\Saudi Arabia CTD Module 1 v1.0.xml No No No No No
\templates\TH eCTD Module 1 v0.92.xml No No No No No
\templates\TH eCTD Module 1 v1.0.xml No No No No No
\templates\TW eCTD Module 1 v1.0.xml N/A New No No No
\templates\UCSampleCoverPageTemplate.docx No No No No No
\templates\UCSampleOverlayTemplate.docx No No No No No
\templates\UCSampleTOCTemplate.docx No No No No No
\templates\US eCTD Module 1 v2.01.xml No No No No No
\templates\US eCTD Module 1 v3.3.xml No Yes No No No
\templates\WHO eCTD Module 1 v1.0.xml New
\templates\ZA eCTD Module 1 v1.0.xml No No No No No
\templates\ZA eCTD Module 1 v2.1.xml No No No No No
\templates\ZA eCTD Module 1 v3.1.xml N/A N/A N/A New No

Sample Templates

Ennov InSight includes additional assembly templates to enable the creation of reports or other electronic submission types. The following templates are samples for the publishing finishing options for overlays, Tables of Contents (TOC), and cover pages. Unicode (UC) templates for TOC, cover pages, and overlays are available (for A4 paper size).

  • A4SampleTOCTemplate.docx
  • SampleCoverPageTemplate.docx
  • SampleOverlayTemplate.docx
  • SampleTOCTemplate.docx
  • UCSampleCoverPageTemplate.docx
  • UCSampleOverlayTemplate.docx
  • UCSampleTOCTemplate.docx