Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGEMENTS
Afficher le documentFOREWORD
Ouvrir ce répertoire et afficher son contenuI. INTRODUCTION
Fermer ce répertoireII. REGULATORY SITUATION
Fermer ce répertoireAfrica
Afficher le documentMali
Afficher le documentMauritius
Afficher le documentSouth Africa
Ouvrir ce répertoire et afficher son contenuThe Americas
Ouvrir ce répertoire et afficher son contenuEastern Mediterranean
Ouvrir ce répertoire et afficher son contenuEurope
Ouvrir ce répertoire et afficher son contenuSouth East Asia
Ouvrir ce répertoire et afficher son contenuWestern Pacific
Afficher le documentIII. CONCLUSION
Afficher le documentIV. REFERENCES

South Africa

Importance of herbal medicines

A large number of South Africans consult traditional healers, mostly in addition to medical practitioners. There are about 200 000 traditional healers in the country, and indigenous herbal medicines are in the main materia medica. Herbal medicines are also used for self-care.

Legal Status

The trade in crude indigenous herbal products is completely unregulated. However, once a health-related claim is made for a finished product, it has to go through the full drug evaluation procedure in the Medicines Control Council (MCC) before marketing [11].

Specific regulations for registration and control of new "traditional" herbal medicines do not exist. Old medicines including some well-known herbal medicines, such as Senna or Aloes, are already registered by the MCC, according to internationally accepted standards of efficacy and safety. Pharmaceutical standards need to be consistent with those of the United States Pharmacopoeia (USP) or the British Pharmacopoeia (BP) [11]. At present, there is no possibility for an abridged application procedure, and there is neither a list of therapeutic indication claims suitable for treatment with traditional medicines, nor a national herbal medicines formulary of a pharmacopoeia [11].

Development Programme

The present regulations of the MCC with respect to traditional herbal medicines are comparable to those of the FDA prior to the Dietary Supplement Health and Education Act of 1994 [11].

Traditional medicines are included in the drug policy section of the government's Reconstruction and Development Programme. The Traditional Medicines Programme (TRAMED) at the Department of Pharmacology, University of Cape Town, participated in formulating an outline proposal for the registration and control of traditional medicines in 1994. The aims of TRAMED are promotion of the use of safe, effective and high quality "essential" traditional medicines, promotion of the documentation of traditional medicines and their scientific validation, contributing to primary health care through the provision of appropriate information to traditional healers and health professionals, support of industrial development in this sector by local industry, and contributing to the training of traditional healers [12].

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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 1 décembre 2019