title: The registration and control of medicines in South Africa: legal issues.
abstract: In the provision of health care medicines occupy a central position, both at primary and more advanced levels. Sound medicines have the capability to control and prevent common diseases, and to alleviate suffering. People's confidence in the health services that are provided by the state and by the private sector (as the case may be) is influenced by their knowledge that the medicines that they receive are of good quality and proven efficacy and safety, and that they are continuously available at reasonable cost. A sound national policy for the provision of safe and cost-effective medicines needs to be based on several elements. The most important are: A sound pharmaceutical industry that is able to function in an atmosphere of confidence, with the knowledge that its efforts in support of the public health are understood and respected; and a drug regulatory authority that is trusted for its expertise, independence and integrity. This is as true for a country such as South Africa as it is for a fully industrialised country such as the United States. The regulation and control of medicines in South Africa falls under the aegis of the Medicines Control Council, a statutory body established in accordance with the Medicines and Related Substances Act. In terms of the Act, the council has the mandate to ensure that the medicines available to the South African public are safe, effective, and of high quality, and that their availability is in the public interest. In considering this, the council may take into account only the scientific data available.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: University of Cape Town, South Africa.
authors.forename: P I
authors.initials: PI
authors.lastname: Folb
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence; D016527:Drug Costs; D004341:Drug Evaluation / Q000145:classification / Q000379:methods / Q000592:standards*; D004358:Drug Therapy / Q000191:economics / Q000592:standards*; D017041:Ethics Committees; D004992:Ethics, Medical; D006801:Humans; D007880:Legislation, Drug; D012042:Registries / Q000592:standards*; D013019:South Africa