Electronic Common Technical Document (eCTD) - Ressources

Objectives

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)

• As part of the West African Medicine Regulatory Harmonization (WA-MRH) project, ECOWAS is implementing an electronic structured format for CTD applications (non-eCTD electronic format).
• Structured electronic formats enable predictability and automatic validation which in turn will increase requirement transparency for industry and reduce initial iterations due to non-compliance. Both industry and Authorities can be assured that the requirement for documents and document quality have been met prior the initial submission.
• The well-organized content provided by structured formats will increase evaluation efficiency and consistency. The goal is to harmonize evaluation processes across the region enabling predictable and reliable evaluation times and decrease the time to needed evaluate and approve submissions.
• The goal is to adapt an eCTD only approach compliant with the international ICH eCTD specifications. As a temporary solution we are also allowing a temporary steppingstone eSubmission solution which shall be used for all submissions moving forward that are not submitted in eCTD format. Please see Timeline information in the specifications for more details.
• Please note that the ECOWAS eSubmission is not the same as the NeeS format implemented in many regions. It is simpler and requires no additional software than that which is normally found in a typical regulatory department of a pharmaceutical company. This should remove all barriers for companies to move swiftly to the new eSubmission format.

eCTD (Electronic Common Technology Document)

• eCTD is the preferred format for electronic submissions.
• eCTD is the official international standard promoted by ICH for applications for human medicines. It is made up (mostly) of PDF leaf documents, stored in the eCTD directory structure, accessed through the XML backbones (index.xml & wa-regional.xml) and guarantees files integrity through MD5 Checksums.
• The eCTD structure enables advanced capabilities that improves application evaluation especially during later life cycle reviews.
• As the international standard format, the eCTD will make exporting locally produced pharmaceuticals to the rest of the world much easier by being conform to expectations and requirements in other markets.
• Compiled Applications can largely be reused without changes for other markets.
• Evaluated and Approved Content that is reused is more likely to be approved without change requests during evaluation.
• Changes in the lifecycle of the application can be quickly and easily applied to other markets.

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

• ECOWAS-WAHO eCTD Specifications EN v1 0
• ECOWAS-WAHO eCTD Specifications FR v1 0
• ECOWAS-WAHO eCTD Specifications PT v1 0
• ECOWAS-WAHO eSubmission Specifications EN v1 0
• ECOWAS-WAHO eSubmission Specifications FR v1 0
• ECOWAS-WAHO eSubmission Specifications PT v1 0
• ECOWAS-WAHO Electronic Applications Validation Criteria v1 0
• ECOWAS-WAHO Electronic Applications Q&A v1 0

Technical Files

• ECOWAS-WAHO util folder (DTD and Style Sheets) for Module 1 v1 0
• Defined Lists & Validation Matrices
• recipient.xml
• application_type.xml
• submission_type.xml
• submission_lead.xml
• sequence_type.xml
• contact_type.xml
• codes.xsl (Style Sheet for Defined Lists)
• document_matrix.xml
• document_matrix.xsl (Style Sheet for Document Matrix)
• submission_type_matrix.xml
• submission_type_matrix.xsl (Style Sheet for Submission Type Matrix)
• Samples
• Sample Applications
• Sample envelope.xml

eSubmission Utility

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

• Creating the correct folder structure for an ECOWAS eSubmission.
• Creating the required ECOWAS regional.xml file for an ECOWAS eSubmission.
• Removing empty folders when compilation is complete.

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.

• LORENZ Life Sciences
• VECTOR Life Sciences

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:

• Implementation Timelines
•  Content Requirements
•  Additional Data required under 1.2.A
•  Additional Data required under 1.A
• Country Specific information required under 2.3.R / 3.2.R

ECOWAS Joint Assessment Procedure (JAP) Summary

The ECOWAS JAP is a collaborative initiative among 15 National Regulatory Agencies in West Africa to streamline market authorization of medical products. It covers essential medicines, life-saving commodities, biological products, and other priority medical supplies. The process involves submission of an Expression of Interest, pre-submission meetings, dossier validation, and a two-phase technical evaluation. Upon approval by the West African Health Organization (WAHO), applicants have 2 years to apply for marketing authorization in ECOWAS member states, which must be granted within 60 days. The JAP offers faster, harmonized regulatory approvals and streamlined administrative procedures, benefiting both applicants and regulatory agencies.

Download Detailed ECOWAS JAP Procedure (PDF)

Payment Process: Screening fee is $500. Evaluation fees vary:

• West Africa Region: $8,000
• Other African regions: $10,000
• Outside Africa: $12,000