Electronic Common Technical Document (eCTD)

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Objectives

The eCTD is the standard format for submitting applications, amendments, supplements, and reports to WAHO's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research.

Electronic Submissions

  • As part of the West African Medicine Regulatory Harmonization (WA-MRH) project. ECOWAS is implementing electronic structured formats for CTD applications.
  • Electronic structured formats enable prodictability and automatic validation whihc 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 requirementfor documents and document quality have been met prior the initial submission.
  • The well organized content provided by structutred formats will increase evaluation efficienty and consistency.The goal is to harmonize evaluation proceses across the region enable predicatble and reliable evaluaton times and decrease the time to 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 stepping stone eSubmission solution whihc shall be used for all submissions moving forward that are not submitted in eCTD format. Please see Timeline information for more details.

eCTD (Electronic Common Technology Document)

  • eCTD is the preferred format for electronic submissions. it 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.

eSubmission (Electronic Submission)

  • eSubmission s a temporary (see timelines) solution made up of collection of organised content conform to very simple defined structure. eSubmissions do allow for validation and content quality checks similar to eCTD submissions but does not allow for complex life cycle operations to be displayed and are therefore less efficient during the evaluation process.

ECOWAS-WAHO Submission Portal

    Electronic submission requirements will apply to the following types of submissions to CDER/CBER:

  • NDAs
  • ANDAs
  • BLAs
  • Commercial IND applications (for products that are intended to be distributed commercially)
  • All subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect
  • Master files, such as DMFs, which are considered to be submissions to an IND, an NDA, an ANDA, or a BLA

ECOWAS-WAHO eCTD & eSubmission Specifications

Technical Files

ECOWAS-WAHO Forms & Related Guidance

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