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.
- 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 | 6.2 CHF 7 | 6.2.8 | 6.2.9 | 6.2.10 | |
| 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 | Build 6.2.0.7.0006 | Build 6.2.0.8 | Build 6.2.0.9.0001 | Build 6.2.0.10.0001 | |
| templates\510k Template (Sep 2019).xml | N/A | N/A | N/A | N/A | New | No | No | No | No | No | No |
| \templates\510k template.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\A4SampleTOCTemplate.docx | No | No | No | No | No | No | No | No | No | No | No |
| \templates\ASEAN ACTD-NeeS.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\AU eCTD Module 1 v0.90.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\AU eCTD Module 1 v3.0.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\AUS Module 1 CTD v2.1.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\AUS Module 1 CTD-NeeS v2.0 2011.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\AU Module 1 eCTD v3.1.xml | New | No | No | No | No | No | No | No | No | No | No |
| \templates\AU Module 1 NeeS v2.0.xml | New | No | No | No | No | No | No | No | No | No | No |
| \templates\Canadian eCTD Module 1 v1.0.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\Canadian eCTD Module 1 v2.2.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\Canadian electronic CTA CTA-A-29-May-2013.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\Canadian electronic CTA.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.0.1.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.1.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.2.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.3.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.4.xml | N/A | N/A | New | Yes | No | No | No | No | No | No | No |
| \templates\CH eCTD Module 1 v1.5.xml | N/A | N/A | N/A | N/A | N/A | New | No | No | No | No | No |
| \templates\CN eCTD Module 1 v1.0.xml | N/A | N/A | N/A | N/A | New | No | No | No | Yes | No | No |
| \templates\CN eCTD ICH Module 2-5 v3.2.xml | N/A | N/A | N/A | N/A | New | No | No | No | Yes | No | No |
| \templates\CN Clinical Study Report (VV5-0).xml | N/A | N/A | N/A | N/A | New | No | No | No | Yes | No | No |
| \templates\CN Nonclinical Study Report (SEND Dataset).xml | N/A | N/A | N/A | N/A | New | No | No | No | No | No | No |
| \templates\CN Nonclinical Study Report.xml | N/A | N/A | N/A | N/A | New | No | No | No | No | No | No |
| \templates\eCTD ICH Module 2-5 v3.2.xml | No | No | Yes | No | No | No | No | No | No | No | No |
| \templates\EAEU Template v1.0.xml | N/A | N/A | N/A | N/A | New | Yes | Yes | No | No | No | Yes |
| \templates\EU CTA.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.0 - CP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.0 - MRP-DCP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.0 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.1 - CP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.1 - MRP-DCP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.1 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.2.1 - CP.xml | No | No | No | No | 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 | No | No | No | No |
| \templates\EU eCTD Module 1 v1.2.1 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.3 - CP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.3 - MRP-DCP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.3 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.4 - CP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.4 - MRP-DCP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v1.4 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v2.0 - CP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v2.0 - MRP-DCP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v2.0 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0 - CP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0 - MRP-DCP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.1 - CP.xml | No | No | No | No | 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 | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.1 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.3 - CP.xml | New | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.3 - MRP-DCP.xml | New | No | No | No | No | No | No | No | No | No | No |
| \templates\EU eCTD Module 1 v3.0.3 - NP.xml | New | No | No | No | No | No | No | No | No | No | No |
| \templates\EU IMPD template.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU PMF Submission in eCTD.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU VNeeS - Immunological.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU VNeeS - Pharmaceutical.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU VNeeS v2.2 - Immunological.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU VNeeS v2.2 - MRL Maximum Residue Limits.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU VNeeS v2.2- Pharmaceutical.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU VNeeS v2.3 - Immunological.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU VNeeS v2.3 - MRL Maximum Residue Limits.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\EU VNeeS v2.3- Pharmaceutical.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\GCC eCTD Module 1 v1.2 - GCC.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\GCC eCTD Module 1 v1.2 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\GCC eCTD Module 1 v1.5 - GCC.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\GCC eCTD Module 1 v1.5 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\HR eCTD Module 1 v1.4 - NP.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\ICH E3 Clinical Study Report (VV2-2).xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\ICH E3 Clinical Study Report (VV3-0).xml | No | No | No | No | 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 | No | No | No | No |
| \templates\JO eCTD Module 1 v1.0.xml | N/A | N/A | N/A | New | No | No | No | No | No | No | No |
| \templates\JO eCTD Module 1 v1.1.xml | N/A | N/A | N/A | N/A | N/A | N/A | New | No | No | No | No |
| \templates\JP eCTD Module 1 v1.0.xml | N/A | N/A | Yes | No | No | No | No | No | No | No | No |
| \templates\JP eCTD Module 2-5 v3.2.xml | No | No | No | No | 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 | No | No | No | No |
| \templates\MD - IMDRF nIVD Template.xml | N/A | N/A | N/A | N/A | New | No | No | No | No | No | No |
| \templates\Nonclinical Study Report (SEND Dataset).xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\Nonclinical Study Report.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\PMA Template (Feb 2019).xml | N/A | N/A | N/A | N/A | New | No | No | No | No | No | No |
| \templates\PMA Template.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\ROW CTD Module 1.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\SampleCoverPageTemplate.docx | No | No | No | No | No | No | No | No | No | No | No |
| \templates\SampleOverlayTemplate.docx | No | No | No | No | No | No | No | No | No | No | No |
| \templates\SampleTOCTemplate.docx | No | No | No | No | No | No | No | No | No | No | No |
| \templates\Saudi Arabia CTD Module 1 v1.0.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\TH eCTD Module 1 v0.92.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\TH eCTD Module 1 v1.0.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\TW eCTD Module 1 v1.0.xml | N/A | N/A | N/A | N/A | N/A | N/A | N/A | New | No | No | No |
| \templates\UCSampleCoverPageTemplate.docx | No | No | No | No | No | No | No | No | No | No | No |
| \templates\UCSampleOverlayTemplate.docx | No | No | No | No | No | No | No | No | No | No | No |
| \templates\UCSampleTOCTemplate.docx | No | No | No | No | No | No | No | No | No | No | No |
| \templates\US eCTD Module 1 v2.01.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\US eCTD Module 1 v3.3.xml | No | No | Yes | No | No | No | No | Yes | No | No | No |
| \templates\ZA eCTD Module 1 v1.0.xml | No | No | No | No | No | No | No | No | No | No | No |
| \templates\ZA eCTD Module 1 v2.1.xml | No | No | No | No | 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