Complementary and traditional health products are now subject to increasing regulatory oversight in South Africa, driven by SAHPRA evolving mandate. Once considered outside the formal regulatory scope, CTMs are now under increasing scrutiny by the South African Health Products Regulatory Authority (SAHPRA). This shift signals the government’s intent to ensure that all health-related products regardless of origin meet minimum standards of safety, quality, and efficacy.
For manufacturers, marketers, and importers of CTMs, navigating SAHPRA’s regulatory framework is no longer optional, it’s essential. Understanding how these products are categorized, assessed, and approved can mean the difference between compliant market access and enforcement action.
SAHPRA Mandate and the CTM Framework
SAHPRA, established under the Medicines and Related Substances Act (Act 101 of 1965), is responsible for the scientific evaluation and registration of all health products in South Africa. In 2013, the regulatory framework was extended to include complementary and traditional medicines under the broader category of Category D products.
Key Definitions Under Category D:
- Complementary Medicines (CMs): Products based on traditional philosophies (e.g., Ayurveda, Homeopathy) but not necessarily indigenous to South Africa.
- Traditional Medicines (TMs): Products based on indigenous African beliefs and traditional practices.
These products must now demonstrate:
- Quality: Evidence of GMP-compliant manufacturing
- Safety: Toxicological profiles and adverse event reporting mechanisms
- Efficacy: Scientific or traditional use evidence
Product Classification: The First Critical Step
Before a product dossier is even submitted, classification is vital. SAHPRA distinguishes CTMs based on:
- Philosophical system of use (e.g., Unani, Traditional Chinese Medicine, African Traditional Medicine)
- Composition (herbs, minerals, homeopathic ingredients)
- Intended purpose (therapeutic claims vs general wellness)
Incorrect classification can delay approvals or lead to regulatory rejection. Therefore, sponsors are encouraged to submit a classification request form to SAHPRA before compiling the full dossier.
Registration Pathways for CTMs
SAHPRA currently offers three main regulatory pathways depending on the product’s history, risk, and evidence base:
- Full Registration Pathway
For new or high-risk CTMs that make therapeutic claims, a full dossier including Modules 1–5 (as per the CTD format) is required. This includes:
- Clinical data or traditional use documentation
- Non-clinical safety data
- GMP certification
- Notification Pathway (for lower-risk products)
Some products may qualify under the notification scheme (e.g., vitamins, minerals, and low-risk herbal combinations). This requires:
- Product composition
- GMP confirmation
But does not require efficacy data, provided no disease claims are made.
- Exemption/Grandfathering
Older products marketed before November 2013 may qualify for exemption provided:
- No safety concerns have arisen
- The product stays within original formulation and labeling boundaries
However, SAHPRA is phasing out this status in favor of active reassessment.
Dossier Requirements: What Sponsors Must Prepare
A well-prepared CTM dossier should include:
- Module 1: Administrative info, local representation, labeling
- Module 2: Summaries of quality, safety, efficacy
- Module 3: Chemistry, Manufacturing & Controls (CMC)
- Module 4: Non-clinical data (if applicable)
- Module 5: Clinical or traditional evidence (e.g., pharmacopeial references, monographs, published literature)
Traditional use evidence must demonstrate continuous use over at least 30 years, 15 of which must be in South Africa or similar markets.
Labelling, Advertising & Post-Marketing Surveillance
SAHPRA has tightened controls around product claims, labelling and advertising, particularly where therapeutic benefit is implied.
- Claims must be consistent with submitted evidence.
- Labels must avoid misleading terms like “cure” or “guaranteed relief”.
- All CTMs are subject to pharmacovigilance (PV) obligations, including adverse event reporting.
Sponsors must also comply with GMP inspection requirements for local and imported products, and SAHPRA reserves the right to perform post-marketing surveillance on all Category D products.
Common Pitfalls in CTM Registration
- Assuming traditional use exempts clinical data
→ Not true for products making strong therapeutic claims. - Underestimating GMP requirements
→ Even herbal teas must be manufactured under licensed conditions. - Using outdated monographs or literature
→ Acceptable evidence must be recent, relevant, and aligned with SAHPRA’s guidance. - Ignoring PV obligations post-registration
→ Adverse event monitoring is a regulatory requirement for all registered CTMs.
Conclusion
South Africa offers a significant market opportunity for CTMs, driven by both consumer demand and rich traditional knowledge. But with opportunity comes responsibility. SAHPRA’s framework brings much-needed structure to the sector, and sponsors who proactively align with these requirements will gain faster, safer, and more credible market entry.
How can DDReg help?
At DDReg, we support clients across the CTM lifecycle, from classification to registration and post-market compliance. Our capabilities include:
- Strategic classification guidance for complementary and traditional medicines
- CTD dossier preparation tailored to SAHPRA’s requirements
- Literature searches and traditional use evidence compilation
- Label compliance checks and advertising advisory
- Local representation and submission management
- GMP and PV support for ongoing regulatory obligations
With deep regulatory expertise in emerging markets, we help sponsors bring CTMs to the South African market, compliantly and efficiently.
Read more from DDReg experts here: Post-Market Evidence Generation: Bridging PV and HTA for Long-Term Access