SAHPRA eCTD Submission Updates
SAHPRA eCTD Portal Launch:
Beginning
October 1, 2024, SAHPRA mandates all applications to be submitted via its
eCTD Portal. Through this portal, applicants can register, upload content, and manage submission sequences. Detailed instructions are provided in the
SAHPRA eCTD Portal Process Guide.
This transition to eCTD boosts submission efficiency, improves international market access, and ensures that companies remain compliant with regulatory standards.
SAHPRA eCTD Specifications Updates
SAHPRA has updated the technical and procedural requirements for electronic submissions through a series of key documents:
- ZA-SAHPRA eCTD Specifications v3.1: Guidelines for structuring submissions.
- ZA-SAHPRA eCTD Validation Criteria v3.1: Rules for ensuring compliance and validating submissions.
- ZA-SAHPRA eCTD Q&A v5.0: Frequently asked questions on eCTD processes.
- ZA-SAHPRA CTD eSubmission Specification v3.1: Detailed submission requirements.
Related technical files:
- SAHPRA util folder: Includes DTD, style sheets, MD5 checksums, and XML trigger files for structuring Module 1 of the eCTD.
- Defined Lists & Validation Matrices: Various XML files (application types, document matrices, etc.) for validation and classification.
- Samples: Examples of comprehensive eCTD element samples and trigger files (e.g., envelope.xml).
These documents provide essential guidance for correctly formatting and validating eCTD submissions.
To access and download the technical files, please visit the following link: https://ectd.sahpra.org.za/
