Calyx RIM 6.2 CHF 6 Upgrade Guidelines

eCTD Template Files

Calyx RIM 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 current version of each listed template file on your system, refer to the Modified/Introduced in Version column in the Template Files table. This column contains information about the template status for every version in the Calyx RIM6.2 branch:
  • No - template was not updated
  • Yes - template was updated
  • New - template introduced or updated
  • N/A - template did not exist for the release
Template Modified/Introduced in Version
6.2 6.2 CHF 1 6.2 CHF 2 6.2 CHF 3 6.2 CHF 4 6.2 CHF 5 6.2 CHF 6
Build 6.2.0.0.0296 Build 6.2.0.1.0004 Build 6.2.0.2.0069 Build 6.2.0.3.0039 Build 6.2.0.4.0079 Build 6.2.0.5.0055 Build 6.2.0.6.0007
templates\510k Template (Sep 2019).xml N/A N/A N/A N/A New No No
\templates\510k template.xml No No No No No No No
\templates\A4SampleTOCTemplate.docx No No No No No No No
\templates\ASEAN ACTD-NeeS.xml No No No No No No No
\templates\AU eCTD Module 1 v0.90.xml No No No No No No No
\templates\AU eCTD Module 1 v3.0.xml No No No No No No No
\templates\AUS Module 1 CTD v2.1.xml No No No No No No No
\templates\AUS Module 1 CTD-NeeS v2.0 2011.xml No No No No No No No
\templates\AU Module 1 eCTD v3.1.xml New No No No No No No
\templates\AU Module 1 NeeS v2.0.xml New No No No No No No
\templates\Canadian eCTD Module 1 v1.0.xml No No No No No No No
\templates\Canadian eCTD Module 1 v2.2.xml No No No No No No No
\templates\Canadian electronic CTA CTA-A-29-May-2013.xml No No No No No No No
\templates\Canadian electronic CTA.xml No No No No No No No
\templates\CH eCTD Module 1 v1.0.1.xml No No No No No No No
\templates\CH eCTD Module 1 v1.1.xml No No No No No No No
\templates\CH eCTD Module 1 v1.2.xml No No No No No No No
\templates\CH eCTD Module 1 v1.3.xml No No No No No No No
\templates\CH eCTD Module 1 v1.4.xml N/A N/A New Yes No No No
\templates\CH eCTD Module 1 v1.5.xml N/A N/A N/A N/A N/A New No
\templates\CN eCTD Module 1 v1.0.xml N/A N/A N/A N/A New No No
\templates\CN eCTD ICH Module 2-5 v3.2.xml N/A N/A N/A N/A New No No
\templates\CN Clinical Study Report (VV5-0).xml N/A N/A N/A N/A New No No
\templates\CN Nonclinical Study Report (SEND Dataset).xml N/A N/A N/A N/A New No No
\templates\CN Nonclinical Study Report.xml N/A N/A N/A N/A New No No
\templates\eCTD ICH Module 2-5 v3.2.xml No No Yes No No No No
\templates\EAEU Template v1.0.xml N/A N/A N/A N/A New Yes Yes
\templates\EU CTA.xml No No No No No No No
\templates\EU eCTD Module 1 v1.0 - CP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.0 - MRP-DCP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.0 - NP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.1 - CP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.1 - MRP-DCP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.1 - NP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.2.1 - CP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.2.1 - MRP-DCP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.2.1 - NP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.3 - CP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.3 - MRP-DCP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.3 - NP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.4 - CP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.4 - MRP-DCP.xml No No No No No No No
\templates\EU eCTD Module 1 v1.4 - NP.xml No No No No No No No
\templates\EU eCTD Module 1 v2.0 - CP.xml No No No No No No No
\templates\EU eCTD Module 1 v2.0 - MRP-DCP.xml No No No No No No No
\templates\EU eCTD Module 1 v2.0 - NP.xml No No No No No No No
\templates\EU eCTD Module 1 v3.0 - CP.xml No No No No No No No
\templates\EU eCTD Module 1 v3.0 - MRP-DCP.xml No No No No No No No
\templates\EU eCTD Module 1 v3.0 - NP.xml No No No No No No No
\templates\EU eCTD Module 1 v3.0.1 - CP.xml No No No No No No No
\templates\EU eCTD Module 1 v3.0.1 - MRP-DCP.xml No No No No No No No
\templates\EU eCTD Module 1 v3.0.1 - NP.xml No No No No No No No
\templates\EU eCTD Module 1 v3.0.3 - CP.xml New No No No No No No
\templates\EU eCTD Module 1 v3.0.3 - MRP-DCP.xml New No No No No No No
\templates\EU eCTD Module 1 v3.0.3 - NP.xml New No No No No No No
\templates\EU IMPD template.xml No No No No No No No
\templates\EU PMF Submission in eCTD.xml No No No No No No No
\templates\EU VNeeS - Immunological.xml No No No No No No No
\templates\EU VNeeS - Pharmaceutical.xml No No No No No No No
\templates\EU VNeeS v2.2 - Immunological.xml No No No No No No No
\templates\EU VNeeS v2.2 - MRL Maximum Residue Limits.xml No No No No No No No
\templates\EU VNeeS v2.2- Pharmaceutical.xml No No No No No No No
\templates\EU VNeeS v2.3 - Immunological.xml No No No No No No No
\templates\EU VNeeS v2.3 - MRL Maximum Residue Limits.xml No No No No No No No
\templates\EU VNeeS v2.3- Pharmaceutical.xml No No No No No No No
\templates\GCC eCTD Module 1 v1.2 - GCC.xml No No No No No No No
\templates\GCC eCTD Module 1 v1.2 - NP.xml No No No No No No No
\templates\GCC eCTD Module 1 v1.5 - GCC.xml No No No No No No No
\templates\GCC eCTD Module 1 v1.5 - NP.xml No No No No No No No
\templates\HR eCTD Module 1 v1.4 - NP.xml No No No No No No No
\templates\ICH E3 Clinical Study Report (VV2-2).xml No No No No No No No
\templates\ICH E3 Clinical Study Report (VV3-0).xml No No No No No No No
\templates\ICH E3 Clinical Study Report (VV5-0).xml N/A N/A New No No No No
\templates\JO eCTD Module 1 v1.0.xml N/A N/A N/A New No No No
\templates\JO eCTD Module 1 v1.1.xml N/A N/A N/A N/A N/A N/A New
\templates\JP eCTD Module 1 v1.0.xml N/A N/A Yes No No No No
\templates\JP eCTD Module 2-5 v3.2.xml No No No No No No No
\templates\MD - IMDRF (HC) IVD Template.xml N/A N/A N/A N/A New No No
\templates\MD - IMDRF nIVD Template.xml N/A N/A N/A N/A New No No
\templates\Nonclinical Study Report (SEND Dataset).xml No No No No No No No
\templates\Nonclinical Study Report.xml No No No No No No No
\templates\PMA Template (Feb 2019).xml N/A N/A N/A N/A New No No
\templates\PMA Template.xml No No No No No No No
\templates\ROW CTD Module 1.xml No No No No No No No
\templates\SampleCoverPageTemplate.docx No No No No No No No
\templates\SampleOverlayTemplate.docx No No No No No No No
\templates\SampleTOCTemplate.docx No No No No No No No
\templates\Saudi Arabia CTD Module 1 v1.0.xml No No No No No No No
\templates\TH eCTD Module 1 v0.92.xml No No No No No No No
\templates\TH eCTD Module 1 v1.0.xml No No No No No No No
\templates\UCSampleCoverPageTemplate.docx No No No No No No No
\templates\UCSampleOverlayTemplate.docx No No No No No No No
\templates\UCSampleTOCTemplate.docx No No No No No No No
\templates\US eCTD Module 1 v2.01.xml No No No No No No No
\templates\US eCTD Module 1 v3.3.xml No No Yes No No No No
\templates\ZA eCTD Module 1 v1.0.xml No No No No No No No
\templates\ZA eCTD Module 1 v2.1.xml No No No No No No No

Sample Templates

Calyx RIM 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