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

  1. provide us with a link or copy of the current specification for the structure you are requesting or
  2. 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

Botswana Map

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

East African Community

Format:
Configuration:

Specification Version:

docuBridge Version: 5.9.1

Last Updated: 2017-05-30

  • Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.

ET Ethiopia

Ethiopia Map

Format:
Configuration:

Specification Version:

docuBridge Version: 5.10

Last Updated: 2017-05-30

  • Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.

GH Ghana

Ghana Map

Format:
Configuration:

Specification Version:

docuBridge Version: 23.1

Last Updated: 2022-08-04

  • Tab Sheet and Header and Footer section definitions added so the eCTD Attributes are automatically inserted.

KE Kenya

Kenya Map

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

Namibia Map

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

Nigeria Map

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

Rwanda Map

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

SADC Flag

Format:
Configuration:

docuBridge Version: 23.1

CTD
Generic

Last Updated: 2023-08-16

ZA South Africa

South Africa Map

Format:
Configuration:

Specification Version:

docuBridge Version: 5.9.1

eCTD
Innovator, Generic & Nutritional Products

Last Updated 2021-10-21

  • Template has been optimised for Assisted Compilation starting with docuBridge version 21.2 and newer


Please Note: For prior versions please contact us for the older template or an update of your docuBridge software

TZ Tanzania

Tanzania Map

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.

UG Uganda

Uganda Map

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

Zambia Map

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

Zimbabwe Map

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.

COMING SOON:

IMDRF – IVD
IMDRF – Non-IVD