Guidelines for Clinical Study of Traditional Medicines in the WHO African Region

ABSTRACT

WHO Regional Office for Africa, in collaboration with the Department of Essential Drugs and Medicines Policy, WHO, organized a series of regional workshops on the regulation of traditional medicinesleading to the publication of this document. The guidelines were subsequently used to train representatives of national drug regulatory authorities from a number of countries within the WHO African Region. The guidelines have been developed to facilitate the registration, marketing and distribution of traditional medicines of assured quality in the WHO African Region. A key section of the guidelines involves the classification of traditional medicines (which can range from the traditional health practitioner's remedies to the traditional medicine derived from scientific research) according to the mode of preparation, the indication and the extent of development of the remedy. Use of this classification system is meant to assist the work of national drug regulatory authorities to assess documentation submitted with the applications for registration of herbal medicines. The guidelines also set out proposals regarding the minimum regulatory requirements for the registration of each category of traditional medicine in terms of the quality of raw plant materials as well as the quality, safety and efficacy of the finished product.