eCTD and NeeS Template Files
Ennov InSight includes ICH-compliant eCTD and NeeS 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 7.3 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 | ||||
|---|---|---|---|---|---|
| 7.3 | 7.3.1 | 7.3.2 | 7.3.3 | 7.3.4 | |
| templates\510k Template (Sep 2019).xml | No | No | No | No | |
| \templates\510k Template.xml | No | No | No | No | |
| \templates\A4SampleTOCTemplate.docx | No | No | No | No | |
| \templates\ASEAN ACTD-NeeS.xml | No | No | No | No | |
| \templates\AU eCTD Module 1 v0.90.xml | No | No | No | No | |
| \templates\AU\AU Module 1 NeeS v2.0.xml | No | No | No | No | |
| \templates\AU\AU eCTD Module 1 v3.0.xml | No | No | No | No | |
| \templates\AU\AU Module 1 eCTD v3.1.xml | No | No | No | No | |
| \templates\AU\AU Module 1 eCTD v3.2.xml | New | ||||
| \templates\AUS\AUS Module 1 CTD v2.1.xml | No | No | No | No | |
| \templates\AUS\AUS Module 1 CTD-NeeS v2.0 2011.xml | No | No | No | No | |
| \templates\CAN\Canadian eCTD Module 1 v1.0.xml | No | No | No | No | |
| \templates\CAN\Canadian eCTD Module 1 v2.2.xml | No | No | No | No | |
| \templates\CAN\Canadian electronic CTA CTA-A-29-May-2013.xml | No | No | No | No | |
| \templates\CAN\Canadian electronic CTA.xml | No | No | No | No | |
| \templates\CH\CH eCTD Module 1 v1.0.1.xml | No | No | No | No | |
| \templates\CH\CH eCTD Module 1 v1.1.xml | No | No | No | No | |
| \templates\CH\CH eCTD Module 1 v1.2.xml | No | No | No | No | |
| \templates\CH\CH eCTD Module 1 v1.3.xml | No | No | No | No | |
| \templates\CH\CH eCTD Module 1 v1.4.xml | No | No | No | No | |
| \templates\CH\CH eCTD Module 1 v1.5.xml | No | No | No | No | |
| \templates\CN\CN eCTD Module 1 v1.0.xml | No | No | No | No | |
| \templates\CN\CN eCTD ICH Module 2-5 v3.2.xml | No | No | No | No | |
| \templates\CN\CN Clinical Study Report (VV5-0).xml | No | No | No | No | |
| \templates\CN\CN Nonclinical Study Report (SEND Dataset).xml | No | No | No | No | |
| \templates\CN\CN Nonclinical Study Report.xml | No | No | No | No | |
| \templates\CN\CN eSub Supplementary Application - Chinese Medicine v1.0.xml | New | ||||
| \templates\CN\CN eSub Supplementary Application - Chemical Drugs v1.0.xml | New | ||||
| \templates\CN\CN eSub Supplementary Application - the MAH change v1.0.xml | New | ||||
| \templates\CN\CN eSub CTA - MAA - Chemical-Biological-DMF v1.0.xml | New | ||||
| \templates\CN\CN eSub CTA - MAA - Chinese Medicine v1.0.xml | New | ||||
| \templates\CN\CN eSub Consistency evaluation of chemical drugs - Oral v1.0 | New | ||||
| \templates\CN\CN eSub Consistency evaluation of chemical drugs - Oral CTD v1.0.xml | New | ||||
| \templates\CN\CN eSub Consistency evaluation of chemical drugs - Injection v1.0.xml | New | ||||
| \templates\CN\CN eSub Consistency evaluation of chemical drugs - Injection CTD v1.0 | New | ||||
| \templates\CN\CN eSub Renewal Applications - Drug Product v1.0 | New | ||||
| \templates\CN\CN eSub Renewal Applications - Drug Substance v1.0 | New | ||||
| \templates\CN\CN eSub One time import v1.0 | New | ||||
| \templates\CN\CN eSub Dossiers review process v1.0 | New | ||||
| \templates\CN\CN eSub Excipients v1.0 | New | ||||
| \templates\CN\CN eSub Registration drug packaging v1.0 | New | ||||
| \templates\eCTD ICH Module 2-5 v3.2.xml | No | No | No | No | |
| \templates\EAEU\EAEU Template v1.0.xml | No | No | No | No | |
| \templates\EU\EU CTA.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.0 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.0 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.0 - NP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.1 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.1 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.1 - NP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.2.1 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.2.1 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.2.1 - NP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.3 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.3 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.3 - NP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.4 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.4 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v1.4 - NP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v2.0 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v2.0 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v2.0 - NP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0 - NP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0.1 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0.1 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0.1 - NP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0.3 - CP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0.3 - MRP-DCP.xml | No | No | No | No | |
| \templates\EU\EU eCTD Module 1 v3.0.3 - NP.xml | 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\EU IMPD template.xml | No | No | No | No | |
| \templates\EU\EU PMF Submission in eCTD.xml | No | No | No | No | |
| \templates\EU\EU VNeeS - Immunological.xml | No | No | No | No | |
| \templates\EU\EU VNeeS - Pharmaceutical.xml | No | No | No | No | |
| \templates\EU\EU VNeeS v2.2 - Immunological.xml | No | No | No | No | |
| \templates\EU\EU VNeeS v2.2 - MRL Maximum Residue Limits.xml | No | No | No | No | |
| \templates\EU\EU VNeeS v2.2- Pharmaceutical.xml | No | No | No | No | |
| \templates\EU\EU VNeeS v2.3 - Immunological.xml | No | No | No | No | |
| \templates\EU\EU VNeeS v2.3 - MRL Maximum Residue Limits.xml | No | No | No | No | |
| \templates\EU\EU VNeeS v2.3- Pharmaceutical.xml | No | No | No | No | |
| \templates\GCC\GCC eCTD Module 1 v1.2 - GCC.xml | No | No | No | No | |
| \templates\GCC\GCC eCTD Module 1 v1.2 - NP.xml | No | No | No | No | |
| \templates\GCC\GCC eCTD Module 1 v1.5 - GCC.xml | No | No | No | No | |
| \templates\GCC\GCC eCTD Module 1 v1.5 - NP.xml | No | No | No | No | |
| \templates\HR\HR eCTD Module 1 v1.4 - NP.xml | No | No | No | No | |
| \templates\study reports\ICH E3 Clinical Study Report (VV2-2).xml | No | No | No | No | |
| \templates\study reports\ICH E3 Clinical Study Report (VV3-0).xml | No | No | No | No | |
| \templates\study reports\ICH E3 Clinical Study Report (VV5-0).xml | No | No | No | No | |
| \templates\study reports\Nonclinical Study Report (SEND Dataset).xml | No | No | No | No | |
| \templates\study reports\Nonclinical Study Report.xml | No | No | No | No | |
| \templates\JO\JO eCTD Module 1 v1.0.xml | No | No | No | No | |
| \templates\JO\JO eCTD Module 1 v1.1.xml | No | No | No | No | |
| \templates\JP\JP eCTD Module 1 v1.0.xml | No | No | No | No | |
| \templates\JP\JP eCTD Module 2-5 v3.2.xml | No | No | No | No | |
| \templates\MD - IMDRF (HC) IVD Template.xml | No | No | No | No | |
| \templates\MD - IMDRF nIVD Template.xml | No | No | No | No | |
| \templates\PMA Template (Feb 2019).xml | No | No | No | No | |
| \templates\PMA Template.xml | No | No | No | No | |
| \templates\ROW CTD Module 1.xml | No | No | No | No | |
| \templates\SampleCoverPageTemplate.docx | No | No | No | No | |
| \templates\SampleOverlayTemplate.docx | No | No | No | No | |
| \templates\SampleTOCTemplate.docx | No | No | No | No | |
| \templates\SA\Saudi Arabia CTD Module 1 v1.0.xml | No | No | No | No | |
| \templates\TH\TH eCTD Module 1 v0.92.xml | No | No | No | No | |
| \templates\TH\TH eCTD Module 1 v1.0.xml | No | No | No | No | |
| \templates\TW\TW eCTD Module 1 v1.0.xml | No | No | No | No | |
| \templates\UA\UA eCTD Module 1 v1.0.xml | New | ||||
| \templates\UCSampleCoverPageTemplate.docx | No | No | No | No | |
| \templates\UCSampleOverlayTemplate.docx | No | No | No | No | |
| \templates\CNSampleTOCTemplate.docx | New | No | No | ||
| \templates\JPSampleTOCTemplate.docx | New | No | No | ||
| \templates\US\US eCTD Module 1 v2.01.xml | No | No | No | No | |
| \templates\US\US eCTD Module 1 v3.3.xml | Yes | No | No | No | |
| \templates\WHO\WHO eCTD Module 1 v1.0.xml | New | ||||
| \templates\ZA\ZA eCTD Module 1 v1.0.xml | No | No | No | No | |
| \templates\ZA\ZA eCTD Module 1 v2.1.xml | No | No | No | No | |
| \templates\ZA\ZA eCTD Module 1 v3.0.xml | New | No | No | ||
| \templates\ZA\ZA eCTD Module 1 v3.1.xm | New | No | |||
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
- CNSampleTOCTemplate.docx
- JPSampleTOCTemplate.docx