Artemisinin and its derivatives: the regulatory and policy implications for African countries.

In many African countries, the first step for introducing a new drug is its selection on the Essential Drug List (WHO) according to the need, the efficacy, the safety, and the affordability of the product. Requirements for registration of artemisinin and its derivatives are either simple notification or authorization, or full registration. Procedures may vary from country to country, depending upon the level of development of their national regulatory system. The availability of mechanisms to regulate the distribution and the use of these new antimalarials are also depending upon the availability of manpower to implement them. The only artemisinin derivative which has been evaluated clinically in Africa and registered in some African countries, for the treatment of severe and complicated malaria, is intramuscular (i.m.) artemether. The major advantage of artemether is that it is given i.m., thus can be used at peripheral facilities where treatment with intravenous infusions of quinine would not be possible. Post registration surveillance, while being a component of the drug policy of some African countries, has not yet been adequately managed.