LORENZ docuBridge® Application Templates
VECTOR Best Practice LORENZ docuBridge® Application Templates
VECTOR provides templates for African countries requiring CTD free of charge. Many countries have varying expectations of content and structures depending on the type of product or application being submitted. It is important, therefore, to always clarify with the authority any content or structural expectations.
VECTOR provides these templates as a base and expects customers to edit and adjust as needed according to local requirements.
For regions outside of Africa, LORENZ provides templates for countries/regions with eCTD or other specified electronic submissions. LORENZ does not provide templates ad-hoc for countries/regions that do not have official CTD specifications published.
If you do not see the template you require, contact VECTOR and we can create the templates you need free of charge.
We will ask you to either
- provide us with a link or copy of the current specification for the structure you are requesting or
- fill in the Application Template Structure Form with the information of the Level, Structure Number and Node Title of the desired template.
There are instructions in the form. Let us know if you have any questions.
Please Note: If you are running an older docuBridge version than that which is stated here, you may not be able to upload the templates. If you are using a new version, it will be compatible with older version. Please notify VECTOR if you encounter any issues.
BW Botswana

Format:
Configuration:
Specification Version:
docuBridge Version: 23.1
CTD
Generic
Last Updated: 2023-08-16
- Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.
EAC East African Community

Format:
Configuration:
Specification Version:
docuBridge Version: 5.9.1
CTD
Generic
Last Updated: 2017-05-30
- Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.
ET Ethiopia

Format:
Configuration:
Specification Version:
docuBridge Version: 5.10
CTD
Generic
Last Updated: 2017-05-30
- Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.
GH Ghana

Format:
Configuration:
Specification Version:
docuBridge Version: 23.1
CTD
Generic
Last Updated: 2022-08-04
- Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.
KE Kenya

Format:
Configuration:
Specification Version:
docuBridge Version: 5.9.1
CTD
Generic
Last Updated: 2017-11-22
- Initial Creation – Please note that the EAC has defined a structure, it is important to contact the authorities and clarify the structure that should be used.
NA Namibia

Format:
Configuration:
Specification Version:
docuBridge Version: 23.1
CTD
Generic
Last Updated: 2022-08-04
- Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.
NG Nigeria

Format:
Configuration:
Specification Version:
docuBridge Version: 23.1
CTD
Generic
Last Updated: 2022-08-04
- Structure updated to reflect the latest TOC believed to be released in January 2018. NG Module 1 with ICH Module 2-5.
RW Rwanda

Format:
Configuration:
Specification Version:
docuBridge Version: 5.9.1
CTD
Generic
Last Updated: 2017-11-22
- Initial Creation – Please note that the EAC has defined a structure, it is important to contact the authorities and clarify the structure that should be used.
SADC South African Development Community

CTD
Generic
Last Updated: 2023-08-16
ZA South Africa

Format:
Configuration:
Specification Version:
docuBridge Version: 24.1
eCTD
Innovator, Generic & Nutritional Products
Last Updated 2024-10-18
- Template has been optimised for Assisted Compilation starting with docuBridge version 24.1 and newer
Please Note: For prior versions please contact us for the older template or an update of your docuBridge software
TZ Tanzania

Format:
Configuration:
Specification Version:
docuBridge Version: 23.1
CTD
Generic
Last Updated: 2022-08-04
- Initial Creation – Please note that the EAC has defined a structure, it is important to contact the authorities and clarify the structure that should be used.
TN Tunisia

Format:
Configuration:
Specification Version:
CTD
Generic
Last Updated: 2025-02-07
- Initial Creation – Please note that the EAC has defined a structure, it is important to contact the authorities and clarify the structure that should be used.
UG Uganda

Format:
Configuration:
Specification Version:
docuBridge Version: 23.1
CTD
Generic
Last Updated: 2022-08-04
- Initial Creation – Please note that the EAC has defined a structure, it is important to contact the authorities and clarify the structure that should be used.
ZM Zambia

Format:
Configuration:
Specification Version:
docuBridge Version: 23.1
CTD
Generic
Last Updated: 2022-08-04
- Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.
ZW Zimbabwe

Format:
Configuration:
Specification Version:
docuBridge Version: 23.1
CTD
Generic
Last Updated: 2023-08-16
- Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.
Global

CTD
Generic
Last Updated: 2024-11-01
COMING SOON:
IMDRF – IVD
IMDRF – Non-IVD