South Africa
Regulator SAHPRA · South African Health Products Regulatory Authority Official site ↗
eCTD v4.0
Draft / transitionSAHPRA has not announced adoption of eCTD v4.0. South Africa's current eCTD framework is built on the ICH eCTD specification 3.2.2 (the regional Module 1 governed by ZA-SAHPRA eCTD Specifications v3.1), submitted mandatorily via the SAHPRA eCTD Portal since 2024. Watch SAHPRA's eCTD portal page for any future v4.0 roadmap.
Do not expect a v4.0 switch plan for South Africa yet. The current baseline to master is ICH eCTD 3.2.2 with the South African regional Module 1 (ZA-SAHPRA eCTD Specifications v3.1). Build submissions against that, not v4.0.
eCTD v3.2.2 · ZA M1
In forceSAHPRA's eCTD framework is based on the ICH eCTD specification 3.2.2; the regional Module 1 (South African administrative and regional information) is governed by the ZA-SAHPRA eCTD Specifications v3.1, which explicitly states that it is based on the ICH eCTD version 3.2.2 Specification. An eCTD consists of PDF leaf documents held in the eCTD directory structure, accessed through the XML backbones (index.xml and za-regional.xml), with file integrity guaranteed by MD5 checksums. Since 2024, all applications must be submitted through the SAHPRA eCTD Portal and eCTD is the preferred format; eSubmission (electronic CTD) is offered only as a transitional stepping stone for a limited period, with the goal of moving all CTD-based application types to eCTD. Modules 2–5 follow the ICH eCTD 3.2.2 specification.
Build submissions against the ZA-SAHPRA eCTD Specifications v3.1 plus Validation Criteria v3.1.1 and Q&A v5.0. All applications must be submitted through the SAHPRA eCTD Portal (portal.sahpra.org.za); applicants first apply for a login ID and password and register their applications, submissions and each sequence. SAHPRA does not mandate or recommend any particular publishing software; applicants must confirm their tool meets the ZA regional requirements and complete technical validation (Pass/Fail and Best Practice rules) before sending — sequences containing errors are rejected before scientific review. eSubmission is offered only as a transition towards full eCTD.
Notices & updates
FAQ
Is eCTD mandatory at SAHPRA?
Yes. Since 2024, all applications submitted to SAHPRA must go through the SAHPRA eCTD Portal, and eCTD is the agency's preferred electronic submission format. eSubmission (electronic CTD) is offered only as a transitional stepping stone for a limited period, with the goal of moving all CTD-based application types to eCTD; paper and NeeS formats are no longer accepted.
Which version and specification does South Africa use?
It is based on ICH eCTD 3.2.2; the regional Module 1 (South African administrative and regional information) is governed by the ZA-SAHPRA eCTD Specifications v3.1, whose backbone includes index.xml and za-regional.xml, with MD5 checksums. Modules 2–5 follow the ICH eCTD 3.2.2 specification. Submissions go through the SAHPRA eCTD Portal (portal.sahpra.org.za).
Is there an eCTD v4.0 plan for South Africa?
Not yet. SAHPRA has not announced an eCTD v4.0 adoption roadmap; the current eCTD framework is ICH 3.2.2-based (ZA-SAHPRA Specification v3.1). Watch SAHPRA's eCTD portal page for any future roadmap.