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Our medicines regulatory authority: plans for reform in South Africa

Posted 18 October 2012

By Andy Gray 

From the 3rd issue of the NSP Review  

One of the most important building blocks of any effective health system is a fully-functional medicines regulatory authority. In South Africa, this structure, established by an act of parliament, is entrusted with ensuring that the medicines made available in our country are safe, of good quality, and can be expected to have the effect for which they are indicated. 

South Africa first established a medicines regulatory agency in the mid-1960s, in response to the thalidomide disaster. Thalidomide was a medicine marketed to pregnant women which had not been adequately tested for safety. Only when it was used by large numbers of women, particularly in Europe, did it become apparent that the medicine had very serious adverse effects on the growing foetus. The South African Parliament passed the Medicines and Related Substances Control Act in 1965. Read the rest

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