SAHPRA Licenses Hundreds of Herbal Firms Yet Approves Zero Products Under New Safety Rules

SAHPRA has licensed 117 complementary medicine manufacturers across South Africa, yet has not registered a single product for safety or efficacy since establishing its formal regulatory roadmap. That gap, between administrative infrastructure and substantive oversight, defines the current state of the sector. The South African Health Products Regulatory Authority implemented interim controls that include licensing requirements and mandatory labeling warnings. The core registration system, the one requiring full safety and efficacy assessment, remains unapplied across the entire complementary medicines sector. South Africa's medicines legislation dates to 1965. Authorities adopted a phased approach, using call-up notices to systematically identify categories requiring formal registration. By the mid-1980s, new medicines entering the market were required to undergo full registration before sale. In 1986, homeopathic medicines received an exemption from full registration. Manufacturers faced two restrictions: they could not make medical claims about their products, and labels had to carry warnings directing users to consult a medical practitioner, pharmacist, or homeopath. The scope of complementary medicines expanded over the following decades to include Western herbal medicine, traditional Chinese medicine, Unani medicine, aromatherapy, phytotherapy, and various combination products. Health supplements covering vitamins, minerals, amino acids, and probiotics were incorporated into the category, formally designated Category D medicines. In 2013, SAHPRA announced its intention to progressively bring all complementary medicines under effective regulation using a risk-based approach. No complementary medicines have been registered through this process. The original call-up notices issued that year were subsequently repealed. By contrast, legal challenges were reshaping the framework from outside the regulatory process. The Alliance of Natural Health Products of South Africa challenged the regulatory scheme, and the Supreme Court of Appeal decided the case in 2022, ruling that SAHPRA should have no regulatory authority over substances that do not meet the legal definition of a medicine. Draft amendments to the 2017 General Regulations, informed by that judgment, were published for public comment in March 2023 but have not yet been finalized. In the meantime, unregistered complementary medicines must carry a label statement declaring the product has not been evaluated by SAHPRA for quality, safety, or intended use. SAHPRA maintains a searchable database of the 117 licensed manufacturers, importers, and exporters. The public can lodge complaints about complementary medicines through the site, including anonymous complaints. Significant operational gaps remain. The risk-based call-up process has not commenced. Moving from attestation-based licensing to confirmed compliance with current Good Manufacturing Practice standards is still pending. African traditional medicines are not currently captured in the Category D definition at all, leaving an entire body of practice outside the regulatory perimeter entirely. Whether the pending amendments to the 2017 General Regulations, once finalized, will accelerate the call-up process or further redefine which products fall under SAHPRA's authority remains the central unresolved question for the sector.