This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Me
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dicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
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Antimicrobial resistance (AMR) is an important public health concern shared by developed and developing countries. In developing countries the burden of infectious diseases is greater and exacerbate
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d by limited access to, and availability and affordability of, antimicrobials required to treat infections caused by AMR organisms. With drugs not listed on the essential drugs list (EDL), problems of increased morbidity, costs of extended hospitalisation and mortality are extremely serious. The problem of susceptibility to and spread of infections caused by multidrug-resistant (MDR) infectious agents is fuelled by factors such as limited access to clean water and sanitation to ensure personal hygiene, malnutrition, and the HIV/TB epidemic.
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South Africa has faced many challenges over the past two decades, accomplishing profound positive changes in the social structure and government of the nation. This has not yet fully trans
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lated into better health for the population, however, particularly the poorest segment. In fact, the population has lost ground since the 1990s in virtually all important health indicators, leaving South Africa with a high burden of infectious disease.
August 2011, Vol. 101, No. 8 SAMJ
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Guidelines for Handling Temperature Sensitive Vaccines and Pharmaceuticals