Guidelines for Registration of Traditional Medicines in the WHO African Region
(2010; 40 pages)


Traditional medicines have been used by humankind for the treatment of various diseases since long before the advent of orthodox medicine, and to this day, serve the health care needs of the majority of the population living in the WHO African Region. The criteria for evaluating traditional medicines, like those for conventional medicines, are quality (i.e. medicines should be well formulated and possess consistent quality from batch to batch as specified in the official pharmacopoeia chosen as a standard), safety (i.e. medicines should not present risks that are disproportionate to their benefits) and efficacy (i.e. medicines should be effective for the indications claimed and should be clinically significant and useful). However, most traditional medicines that are in use today, many of which are sold to the public via outlets such as open markets, stops and homes, lack scientific evidence of their quality, safety and efficacy. Moreover, the development of regulatory systems for traditional medicines varies widely between countries of the WHO African Region. Less than one third of the countries in the WHO African Region have any form of regulation on traditional medicines. Most countries have yet to establish safety monitoring and pharmacovigilance systems for pharmaceuticals, let alone for herbal medicinal products currently on the market. This scenario poses a unique set of challenges for health care services in the WHO African Region...

These guidelines have been expressly developed in order to facilitate the registration, marketing and distribution of traditional medicines of assured quality in the WHO African Region. This document is particularly relevant to those countries that have already put in place mechanisms for the registration of traditional medicines. I call your attention to the section of the guidelines that is devoted to 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 should assist the work of national drug regulatory authorities when undertaking the assessment of the 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 which will be useful guidance not only to the national drug regulatory authorities, but also to industries and research institutions involved in the development of traditional medicines. Issues related to labelling and advertisement requirements, registration procedures, production authorization and distribution channels, and the organization of pharmacovigilance are also covered.

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