Artemisinin and its derivatives have an essential role to play in the treatment of severe and complicated malaria, and for uncomplicated multidrug-resistant falciparum malaria. Their rapid action and lack of perceived side effects have prompted widespread use. To promote rational use and curtail misuse, drug regulations and policies were formulated through WHO and a multi-disciplinary team of experts. Regulatory policies included prescription and marketing of the artemisinin derivatives only in areas with multidrug-resistant falciparum malaria, for the purpose of treatment (not prophylaxis); prescription in combination with another effective antimalarial, preferably mefloquine; avoidance of drug promotion which would cause consumer misuse, and development of post-marketing surveillance strategies to ensure maximum quality, efficacy, and safety. To promote regulatory standards, guidelines formulated by the World Health Organization were distributed to the national drug regulatory centers of each country, to their ministries of health and to international organizations.