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2 min read
The South African Health Products Regulatory Authority (SAHPRA) is responsible for ensuring the safety, efficacy, and quality of medicines and related substances. For pharmaceutical companies planning to enter the South African market, navigating the SAHPRA drug registration process is a critical step. Below is a structured overview of the end-to-end process.
1) Classify the application & select a review pathway
Decide NCE, biological, generic, line extension, or duplicate. Choose Full, Reliance (abridged), or Priority review based on data and prior approvals from recognized authorities.
2) Appoint the local authorization holder (HCR) & confirm licences
Nominate a South African legal entity as the Holder of the Certificate of Registration. Ensure relevant manufacturing/wholesale licences and GMP evidence are in place for all sites.
3) Map your data strategy
For NCEs/biologicals: align nonclinical/clinical data to CTD expectations. For generics: define BE strategy (reference product, design, endpoints) and stability program (long-term/accelerated) per ICH-aligned practice referenced by SAHPRA guidance.
4) Choose format: eCTD with ZA Module 1
SAHPRA eCTD with ZA-specific Module 1 and regional sections 2.3R/3.2R. Build a complete CTD:
Module 1 (ZA): forms, proof of fee, HCR details, labeling (PI/PIL), risk management, PV contacts.
Module 2: QOS and overviews.
Module 3–5: CMC, nonclinical/clinical or BE.
5) Authoring & publishing
Apply ZA granularity, naming, and lifecycle conventions; prepare a clean sequence with correct submission type and application metadata. Use the latest General/Module 1 guidance to avoid administrative screen-outs.
6) Validate technically
Run the ZA eCTD Validation Criteria in your validator and fix all critical/major errors. For variations and follow-up sequences, check SAHPRA’s Validation Template to mirror what the regulator will verify on receipt.
7) Pay fees & submit electronically
Pay the applicable application fee; include the proof in Module 1. Submit via SAHPRA’s eSubmission channel following ZA eCTD specifications (sequence structure, checksums, lifecycle).
8) Administrative screening
SAHPRA verifies format, completeness, correct forms/fees, labeling, and Module presence. Deficiencies trigger screening queries; resolve via a new sequence referencing the question log.
9) Scientific assessment
Full review: complete CMC/nonclinical/clinical assessment.
- provide proof of reference authority approval and alignment (e.g., unredacted reports where available); SAHPRA focuses on local-context elements.
10) Queries & responses (clock-stops)
Expect quality/clinical/BE/labeling questions. Respond within timelines; submit only changed/added docs with a response summary, following lifecycle rules.
11) Approval & certification
On approval, SAHPRA issues the Certificate of Registration with finalized PI/PIL and scheduling. Market only the registered particulars.
12) Post-registration compliance
- Pay annual retention fees to keep the registration/licence active (due by the last working day of June for 2025).
- File post-approval changes per SAHPRA’s variation processes.
- Maintain safety reporting and risk management.
Pro tips to avoid delays
Use Reliance when eligible to shorten timelines.
Front-load stability/BE plans and ensure labeling fully aligns with the clinical/BE evidence.
- every sequence; most rejections happen at technical/admin stages.
Need hands-on help?
Freyr supports end-to-end SAHPRA submissions—gap assessment, ZA Module 1 authoring, eCTD publishing/validation, reliance packaging, and lifecycle management. Partner with Freyr to fast-track compliant SAHPRA approval. Let’s talk.
