Electronic Common Technical Document (eCTD) - Ressources



The eCTD is the preferred format for submitting applications, amendments, supplements, and reports to WAHO's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. As a steppingstone to eCTD, WAHO will accept applications, etc. in eSubmission format compliant to the specifications provided below.

eSubmission (Electronic Submissions)

eCTD (Electronic Common Technology Document)

ECOWAS-WAHO Submission Portal

All centralised applications being submitted to the ECOWAS region must be submitted via the new ECOWAS eCTD Portal. Both eCTD and eSubmission applications are to be submitted via the Portal.

All applicants will need to apply for a login ID and password to gain access to the portal where they can register their Applications, Submissions, and each Sequence they wish to upload and submit.

Information on how to apply for access and how to upload content can be found in the ECOWAS eCTD Portal Process Guide.

ECOWAS-WAHO eCTD & eSubmission Specifications

Technical Files

eSubmission Utility

For the creation of eSubmission, please download the Free eSubmission Utility. The utility will assist with the following:

Feedback and Comments

Please provide your questions and/or comments using the ECOWAS eCTD Feedback Form and email it to eCTD@wahooas.org. The form is designed to help ECOWAS to categorise and group comments and make it easier to respond. Please do not reformat the form, provide information using the form as it is provided and intended.

eCTD Vendors

ECOWAS does not mandate or recommend any particular software to prepare an eCTD Submission. eCTD is an international standard and any solution capable of producing a valid eCTD will be able to provide an Application compatible with any solution the ECOWAS Authority has chosen to use for evaluation.

Applicants are encouraged to use a proper selection process, understand, and document their user requirements and ensure any solution they select is conform with the ECOWAS regional requirements. A basic sample User Requirements List of helpful functionality has been made available here.

Some eCTD vendors common in most markets are listed below. ECOWAS does not vouch for or recommend any of the vendors. It is entirely up to the Applicant to do their due diligence and ensure they select the correct solution for their needs.

If you are a vendor and would like to be listed here, please contact us at eCTD@wahooas.org and we will be happy to add you to the list once confirmed. Customer references would be helpful.

National Requirements

Information specific to the requirements for National Procedures will be made available here once identified by the National Authorities. This information may include: