What are the World Health Organization's strategies for meeting regulatory requirements? A case study of artesunate.
The basic scope of WHO for developing new drugs or a new indication, is that of responding to a public health need, at an affordable price. This paper describes the approach taken by the organisation for the development of rectal artesunate and the special arrangements and approach which have made this possible for the WHO to meet regulatory requirements. Regulatory submission is planned in Europe and the USA, harmonising the submission, registration and labelling, and this precedent may constitute a worldwide reference for the deployment of the drug. The approach is novel, fast, and unbureaucratic, and can be applied to other drugs meeting a live-saving need.
Tabusso
G
G
Special Programme for Research and Training in Tropical Diseases, TDR/WHO, Geneva, Switzerland.
Gomes
M
M
D000285:Administration, Rectal; D000962:Antimalarials / Q000737:chemistry / Q000627:therapeutic use*; D037621:Artemisinins; D000077332:Artesunate; D002626:Chemistry, Pharmaceutical; D017277:Drug Approval / Q000458:organization & administration*; D005060:Europe; D019317:Evidence-Based Medicine; D006301:Health Services Needs and Demand; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D011634:Public Health; D012042:Registries; D012717:Sesquiterpenes / Q000737:chemistry / Q000627:therapeutic use*; D013997:Time Factors; D014481:United States; D014944:World Health Organization
D000962:Antimalarials; D037621:Artemisinins; D012717:Sesquiterpenes; D000077332:Artesunate