Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentFOREWORD
Open this folder and view contentsI. INTRODUCTION
Close this folderII. REGULATORY SITUATION
Close this folderAfrica
View the documentMali
View the documentMauritius
View the documentSouth Africa
Open this folder and view contentsThe Americas
Open this folder and view contentsEastern Mediterranean
Open this folder and view contentsEurope
Open this folder and view contentsSouth East Asia
Open this folder and view contentsWestern Pacific
View the documentIII. CONCLUSION
View the 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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