Clinical research

Over the last thirty years, South Africa has developed a medicines regulatory authority with internationally recognized standing. Over the past five years, it has been transformed in order to improve its performance and regulatory processes. The Medicines Control Council (MCC) is a statutory body that was established in terms of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the regulation of medicines in South Africa.

A source for evidence-based information about the safety or risk of drugs, chemicals and disease during pregnancy and lactation.

All biomedical research involving human subjects has to comply with established international guidelines that require ethical and scientific review of the research, alongside informed consent. This book sets out operational guidelines for ethics committees in order to facilitate, support, and ensure quality of the ethical review of biomedical research in all countries around the world.

Very useful web site with clinical practice guidelines, full text of Association journals and a compilation of health and medicine-related Internet sites for the use of physicians in their practice and research.

The registrar of medicines, Mandisa Hela, admitted to MPs yesterday that the Medicines Control Council could not cope with its workload, and was in dire need of an overhaul.

Fake and substandard drugs in Africa by immoral medical companies is a serious worry. Malaria continues to be a serious concern. It affects more than 100 countries and about 40percent of the worlds population. It causes between 300 and 500 million infections and about a million deaths each year. It is estimated that malaria kills a child every 30 seconds in spite of the disease being entirely preventable and curable. At the eighth World Health Assembly meeting in 1955, it was resolved to begin a worldwide eradication campaign of malaria. Though the campaign was eventually abandoned and considered a failure, it registered resounding successes in eradicating malaria from large regions across the globe. The successful application of insecticides and the effectiveness of antimalarial treatments formed the cornerstones of the programme.

CAPE TOWN The governments plans to drive down medicine prices by benchmarking them against other countries could cut multinational pharmaceutical firms local revenues by about 35%, say industry sources.

CAPE TOWN Medical Research Council (MRC) president Anthony MBewu yesterday sought to reassure Parliament that the organisations work on the international Ushershell microbicide trial, which was stopped early after 35 women developed HIV, had been conducted to the highest scientific and ethical standards.

Behind the Global Numbers: the Real Costs of Research for Health GENEVA, April 2006-The rich and the privileged enjoy much better health and live much longer than their poorer neighbours, especially those discriminated against because of their caste, class, ethnicity, race or religion, asserts Professor Stephen Matlin, Executive Director of the Geneva-based Global Forum for Health Research.

Better regulation is needed to ensure that research carried out in Africa and other developing countries is ethical, says an expert in this week's BMJ.