Abstract
The regulation and registration of traditional medicines (TM) continues to present challenges to many countries regardless of the fact that an increased number of the population utilises TM for their health care needs. There have been improvements in the legal and policy framework of South Africa based on the WHO guidelines. However, there are currently no guidelines or framework for the registration of TM in South Africa. This article reviews literature and existing guidelines of specific countries and regions and makes recommendations for South African guidelines.
Highlights
Traditional medicines (TM) and plant-based remedies are widely used in Africa
Traditional medicines are defined as the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in prevention, diagnosis, improvement or treatment of physical or mental illnesses (WHO, 2001)
According to the WHO survey on regulation of TM and, herbal medicines showed that 65% of Member States have laws or regulations on herbal medicines and these regulations are largely similar to those of conventional medicines
Summary
Traditional medicines (TM) and plant-based remedies are widely used in Africa. It has been estimated that 80% of the African population relies on traditional forms of medicine to meet their healthcare needs (World Health Organisation (WHO), 2004). A 2005 survey of the WHO on national policy on traditional medicine and regulation of herbal medicines in member countries identified a lot of challenges in the development of such regulations These range from regulatory status, safety and efficacy assessment, quality control and standardisation, safety monitoring and lack of knowledge about traditional, complementary and alternative medicines (TCAM) by relevant national drug regulatory authorities (WHO, 2005). Implementation of such regulatory matters in developing countries where TM still form the backbone of the healthcare systems is hampered by lack of resources. The guidelines to be developed by the MCC expert committee must be guided by the WHO guidelines for registration of traditional and complementary medicines in the African region, which South Africa adopted as a member state (WHO, 2004)
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