Template Files
To make sure that you have the most current version of each listed template file on your system, refer to the Last Modified Build column in the Template Files table. This column displays the product build number in which the file was introduced or updated.
| Component | Customizable | Last Modified Build |
|---|---|---|
| \templates\510k template.xml | No | 6.2.0.0.0296 |
| \templates\A4SampleTOCTemplate.docx | No | 6.2.0.0.0296 |
| \templates\ASEAN ACTD-NeeS.xml | No | 6.2.0.0.0296 |
| \templates\AU eCTD Module 1 v0.90.xml | No | 6.2.0.0.0296 |
| \templates\AU eCTD Module 1 v3.0.xml | No | 6.2.0.0.0296 |
| \templates\AUS Module 1 CTD v2.1.xml | No | 6.2.0.0.0296 |
| \templates\AUS Module 1 CTD-NeeS v2.0 2011.xml | No | 6.2.0.0.0296 |
| \templates\AU Module 1 eCTD v3.1.xml | No | 6.2.0.0.0296 |
| \templates\AU Module 1 NeeS v2.0.xml | No | 6.2.0.0.0296 |
| \templates\Canadian eCTD Module 1 v1.0.xml | No | 6.2.0.0.0296 |
| \templates\Canadian eCTD Module 1 v2.2.xml | No | 6.2.0.0.0296 |
| \templates\Canadian electronic CTA CTA-A-29-May-2013.xml | No | 6.2.0.0.0296 |
| \templates\Canadian electronic CTA.xml | No | 6.2.0.0.0296 |
| \templates\CH eCTD Module 1 v1.0.1.xml | No | 6.2.0.0.0296 |
| \templates\CH eCTD Module 1 v1.1.xml | No | 6.2.0.0.0296 |
| \templates\CH eCTD Module 1 v1.2.xml | No | 6.2.0.0.0296 |
| \templates\CH eCTD Module 1 v1.3.xml | No | 6.2.0.0.0296 |
| \templates\eCTD ICH Module 2-5 v3.2.xml | No | 6.2.0.0.0296 |
| \templates\EU CTA.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.0 - CP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.0 - MRP-DCP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.0 - NP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.1 - CP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.1 - MRP-DCP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.1 - NP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.2.1 - CP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.2.1 - MRP-DCP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.2.1 - NP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.3 - CP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.3 - MRP-DCP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.3 - NP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.4 - CP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.4 - MRP-DCP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v1.4 - NP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v2.0 - CP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v2.0 - MRP-DCP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v2.0 - NP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v3.0 - CP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v3.0 - MRP-DCP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v3.0 - NP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v3.0.1 - CP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v3.0.1 - MRP-DCP.xml | No | 6.2.0.0.0296 |
| \templates\EU eCTD Module 1 v3.0.1 - NP.xml | No | 6.2.0.0.0296 |
| \templates\EU IMPD template.xml | No | 6.2.0.0.0296 |
| \templates\EU PMF Submission in eCTD.xml | No | 6.2.0.0.0296 |
| \templates\EU VNeeS - Immunological.xml | No | 6.2.0.0.0296 |
| \templates\EU VNeeS - Pharmaceutical.xml | No | 6.2.0.0.0296 |
| \templates\EU VNeeS v2.2 - Immunological.xml | No | 6.2.0.0.0296 |
| \templates\EU VNeeS v2.2 - MRL Maximum Residue Limits.xml | No | 6.2.0.0.0296 |
| \templates\EU VNeeS v2.2- Pharmaceutical.xml | No | 6.2.0.0.0296 |
| \templates\EU VNeeS v2.3 - Immunological.xml | No | 6.2.0.0.0296 |
| \templates\EU VNeeS v2.3 - MRL Maximum Residue Limits.xml | No | 6.2.0.0.0296 |
| \templates\EU VNeeS v2.3- Pharmaceutical.xml | No | 6.2.0.0.0296 |
| \templates\GCC eCTD Module 1 v1.2 - GCC.xml | No | 6.2.0.0.0296 |
| \templates\GCC eCTD Module 1 v1.2 - NP.xml | No | 6.2.0.0.0296 |
| \templates\GCC eCTD Module 1 v1.5 - GCC.xml | No | 6.2.0.0.0296 |
| \templates\GCC eCTD Module 1 v1.5 - NP.xml | No | 6.2.0.0.0296 |
| \templates\HR eCTD Module 1 v1.4 - NP.xml | No | 6.2.0.0.0296 |
| \templates\ICH E3 Clinical Study Report (VV2-2).xml | No | 6.2.0.0.0296 |
| \templates\ICH E3 Clinical Study Report (VV3-0).xml | No | 6.2.0.0.0296 |
| \templates\JP eCTD Module 1 v1.0.xml | No | 6.2.0.0.0296 |
| \templates\JP eCTD Module 2-5 v3.2.xml | No | 6.2.0.0.0296 |
| \templates\Nonclinical Study Report (SEND Dataset).xml | No | 6.2.0.0.0296 |
| \templates\Nonclinical Study Report.xml | No | 6.2.0.0.0296 |
| \templates\PMA Template.xml | No | 6.2.0.0.0296 |
| \templates\ROW CTD Module 1.xml | No | 6.2.0.0.0296 |
| \templates\SampleCoverPageTemplate.docx | No | 6.2.0.0.0296 |
| \templates\SampleOverlayTemplate.docx | No | 6.2.0.0.0296 |
| \templates\SampleTOCTemplate.docx | No | 6.2.0.0.0296 |
| \templates\Saudi Arabia CTD Module 1 v1.0.xml | No | 6.2.0.0.0296 |
| \templates\TH eCTD Module 1 v0.92.xml | No | 6.2.0.0.0296 |
| \templates\TH eCTD Module 1 v1.0.xml | No | 6.2.0.0.0296 |
| \templates\UCSampleCoverPageTemplate.docx | No | 6.2.0.0.0296 |
| \templates\UCSampleOverlayTemplate.docx | No | 6.2.0.0.0296 |
| \templates\UCSampleTOCTemplate.docx | No | 6.2.0.0.0296 |
| \templates\US eCTD Module 1 v2.01.xml | No | 6.2.0.0.0296 |
| \templates\US eCTD Module 1 v3.3.xml | No | 6.2.0.0.0296 |
| \templates\ZA eCTD Module 1 v1.0.xml | No | 6.2.0.0.0296 |
| \templates\ZA eCTD Module 1 v2.1.xml | No | 6.2.0.0.0296 |
© 2000-2021 PAREXEL International Corporation and its affiliates. All rights reserved.