[en anglais seulement.CB]
OMS AFRO
Guidelines for Registration of Traditional Medicines in the African Region
http://www.afro.who.int/fr/groupes-organiques-et-programmes/dsd/medicaments-
essentiels/highlights/2732-.html
:: Download the Guidelines for registration of traditional medicines in the
WHO African Region [pdf 5.5MB]
The purpose of this document is to propose to Member States a framework for
facilitating the registration of traditional medicines. The proposed
framework, which has a regional perspective, is intended to accelerate the
registration and circulation of standardized African traditional medicines
within the WHO African Region, on the basis of criteria of pharmaceutical
quality, safety of use and therapeutic efficacy.
The guidelines are aimed at national drug regulatory authorities,
manufacturers, traditional health practitioners and institutions engaged in
drug research and development, who should ensure that their products satisfy
the requirements laid down in this document. The guidelines can also be used
for training and teaching purposes, in particular, for teaching
undergraduate and postgraduate pharmacy, and for training pharmacy
technicians, nurses and medical students, related health professions and
agencies involved in the development of traditional medicine in the WHO
African Region.
Many countries in the WHO African Region are encountering problems in
providing their people with equitable access to health care; at present,
only about one half of the population in the Region has access to
conventional health care. Such considerations aside, traditional medicines
continue to be popular for both historical and cultural reasons.
It has been estimated that around 80% of the population living in the WHO
African Region rely on traditional forms of medicine to meet their health
care needs. In countries for which more detailed data are available, the
percentage of the population that uses traditional medicine ranges from 90%
in Burundi and Ethiopia, to 80% in Burkina Faso, the Democratic Republic of
Congo and South Africa; 70% in Benin, Cote d'Ivoire, Ghana, Mali and Rwanda
and 60% in Tanzania and Uganda.
The document is divided into three parts:
. Part I outlines the history of the development of the guidelines, the
guideline objectives, and a classification system for traditional medicines
. Part II lays down proposals for the minimum regulatory requirements for
the registration of each category of traditional medicine, in terms of the
quality of plant raw materials as well as quality, safety and efficacy of
the finished product and labelling and packaging.
. Part III proposes procedures for the registration of traditional medicines
and addresses a range of issues related to the registration of traditional
medicines, marketing and advertising; post-market surveillance and the
organization of pharmacovigilance; and production authorization and
distribution channels.
A list of further reading, which includes a number of information sources
that were used to support the preparation of the guidelines, is also
provided.