SAHPRA
The South African Health Products Regulatory Authority (SAHPRA) is South Africa’s regulator of medicines and health products. It took over the roles of the Medicines Control Council (MCC) and the Directorate of Radiation Control in 2018. It is a Schedule 3A public entity reporting to the Minister of Health through its Board. Under the Medicines and Related Substances Act 101 of 1965, it registers medicines, licenses manufacturers, wholesalers and distributors, oversees clinical trials, and regulates complementary medicines, medical devices and diagnostics. Its stated pillars are safety, efficacy and quality (SAHPRA, About us). It is the South African counterpart of the UK MHRA, the US FDA and the European Medicines Agency.
SAHPRA [regulates] South African Eczema Guidance SAHPRA [relates] MHRA SAHPRA [relates] FDA
What it means for toddler prescriptions. SAHPRA’s registered age ranges can differ from those overseas. Its approved Dupixent leaflet (revised 13 May 2024) covers Dupilumab for moderate-to-severe atopic dermatitis only from age 6, and says safety and benefit under 6 “are not yet known”. Toddler use in SA is therefore off-label, even though the US and EU license it from 6 months. For Topical Calcineurin Inhibitors, Pimecrolimus is registered in SA for mild-to-moderate eczema from age 2, and Tacrolimus 0.03% for moderate-to-severe eczema from age 2 (Kannenberg 2020). That differs from the UK, where pimecrolimus is licensed from 3 months. For a 1-year-old in SA, both TCIs are off-label.
SAHPRA [regulates] Dupilumab SAHPRA [regulates] Topical Calcineurin Inhibitors
Complementary and herbal products. Since 15 November 2013, complementary medicines have been a regulated “Category D”. This covers six disciplines (aromatherapy, Ayurveda, homeopathy, Traditional Chinese Medicine, Unani Tibb and Western herbal medicine) and, since 2017, health supplements such as probiotics, vitamins and oils. Registration is being phased in through “call-up notices”. Meanwhile, products keep a right of sale only if their makers are licensed, apply on time, and make only low-risk claims: general health, health maintenance, or relief of minor symptoms not linked to a disease (SAHPRA, Complementary Medicines). A product sold in SA as a herbal, homeopathic or aromatherapy “eczema cure” has therefore usually not been assessed by SAHPRA for safety or efficacy in toddlers.
SAHPRA [regulates] Herbal and Home Remedies for Eczema SAHPRA [regulates] Homeopathy SAHPRA [regulates] Probiotics SAHPRA [relates] Traditional Herbal Registration
Unregulated "natural" creams may contain steroids
Creams from markets, traditional healers or online sellers may contain undeclared or unknown-strength topical steroids (see Adulterated Herbal Creams). Use products dispensed by a clinic or pharmacy, with a known strength, and tell the nurse or doctor about any traditional remedy.
Adulterated Herbal Creams [opposes] SAHPRA
Connections
- South African Eczema Guidance — local licensing context, source: SAHPRA Dupixent PIL 2024; Kannenberg 2020
- Dupilumab — SA registration ≥6 years for AD, source: SAHPRA Dupixent PIL 2024
- Topical Calcineurin Inhibitors — SA registration ≥2 years, source: Kannenberg 2020
- Herbal and Home Remedies for Eczema — Category D complementary medicines; low-risk claims only, source: SAHPRA CM page
- Adulterated Herbal Creams — risk of unregistered products with hidden steroids, source: South African Eczema Guidance
- Traditional Herbal Registration — UK equivalent scheme for herbal products, source: SAHPRA CM page; MHRA
- MHRA — UK counterpart regulator, source: SAHPRA About us