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Herbal medicines, herbal medicine legislation, registration process, herbal markers


Unregistered traditional medicines pose a huge public health threat as the safety and efficacy of these products is unknown. The issue this study addresses is the inadequate regulatory measures for herbal medicines in Zimbabwe. This project was done to describe the current registration process of traditional medicines in Zimbabwe, and to identify the gaps and opportunities they present to improve the regulatory landscape. Regulations and laws governing the registration of herbal medicines in the country and published research on legislation of herbal medicines were reviewed. Two parallel regulatory bodies both registering and controlling the sale of herbal medicines were identified. The Medicines Control Authority of Zimbabwe (MCAZ) and the Traditional Medical Practitioners Association (TMPA) both derive their authority to regulate from the ministry of health and were established through the act of parliament which gives these authorities power to regulate the quality and sale of traditional medicines without giving a prescriptive way of doing it. The registration process, and product evaluations for the two authorities are different. While the MCAZ has a clearly defined registration process, the TMPA does not. However, MCAZ has not been very successful in registering local products with the majority of the registered herbal products being imports and only 2% of total registered products being local herbs. As a recommendation, there is need for collaboration between the regulatory bodies for consistence in quality of herbal products on the market and to improve registration of local herbal products. Developing monographs for local herbs commonly used in the country will also assist local manufacturer to fulfill the quality requirements and successful compilation of dossiers for product registration.