Welcome to SAHPRA's
eCTD Submissions Portal

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Objectives

The eCTD is the preferred format for submitting applications, variations to SAHPRA for evaluation, approval and registration.

eCTD (Electronic Common Technical 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 & za-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 makes exporting locally produced pharmaceuticals to the rest of the world much easier as it conforms to expectations and requirements in other markets.
    • Compiled Applications can largely be reused without changes for other markets.
    • Valuated 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.

SAHPRA Submission Portal

Please follow these guidelines when using this portal:

  • All applications being submitted to the SAHPRA must be submitted via the new SAHPRA eCTD 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 SAHPRA eCTD Portal Process Guide.
Download FAQs (PDF) Download FAQs (xls)

SAHPRA eCTD Specifications



2.21 ZA-SAHPRA eCTD Specifications v3.1

2.22 ZA-SAHPRA eCTD Validation Criteria v3.1.1

2.28 ZA-SAHPRA eCTD Q&A v5.0

2.58 ZA-SAHPRA CTD eSubmission Specification v3.1

Related Files

Feedback and Comments

Please provide your questions and/or comments using the SAHPRA eCTD Feedback Form and email it to eCTD@sahpra.org.za. The form is designed to help SAHPRA 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.

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eCTD Vendors

SAHPRA 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 SAHPRA 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 SAHPRA regional requirements.