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-registration
- 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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