South Africa eCTD

Country: South Africa
Health Authority: South African Health Products Regulatory Authority (SAHPRA)
eCTD, Accepted Since: 01-05-2017
eCTD Version: Module 1 Specification v3.0, M2-M5 – v3.2.2 and M1-M5 – v4.0

New application, including:

  • Na-nce-ph: New Chemical Entity – Pharmaceutical
  • Na-nce-b: New Chemical Entity – Biological
  • Na-ms: Multisource
  • Na-bs: Biosimilar
  • Na-le: Line extension
  • Na-cu: Call-up
  • Na-cams: Complementary and Alternative Medicines


  • Post-reg-insp: Inspectorate
  • Post-reg-pa: Pharmaceutical & Analytical
  • Post-reg-pa-insp: Pharmaceutical & Analytical and Inspectorate
  • Post-reg-cl: Clinical
  • Post-reg-pn: Proprietary name change application
  • Post-reg-pn-update: Updates following a proprietary name change approval
  • Post-reg-hcr: Applicant transfer, name and address change of applicant
  • Post-reg-biol: Biologicals and biosimilars
  • Post-reg-cams: Complementary and Alternative Medicines

Response to pre-reg recommendation

  • Pre-reg-pa: Pharmaceutical & Analytical
  • Pre-reg-cl: Clinical
  • Pre-reg-pn: Proprietary name
  • Pre-reg-sch: Scheduling
  • Pre-reg-insp: Inspectorate
  • Pre-reg-pa-insp: Pharmaceutical & Analytical and Inspectorate
  • Pre-reg-biol: Biological committee response
  • Pre-reg-cams: Complementary and Alternative Medicines
  • Pre-reg-cr: Response to Council resolutions

Withdrawal/Cancellation from making a South Africa eCTD submission

  • Withdrawal: Withdrawal of a submission
  • Cancellation: Cancellation of a registered product

Process to be followed to make a South Africa eCTD submission

  • Learn about the ZA M1 Specification for eCTD requirements
  • Review the eCTD submission guidance
  • Submit the application form and compliant PDFs
  • Request for the application number
  • Submit the eCTD submission via electronic media

How can Freyr help?

  • Guarantee your ROI with an eCTD software that optimizes cost-per-submission
  • Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
  • eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.
    For more information on the same, consult us

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