Report: AU-3S Africa focused Report on Safety Data of COVID-19 related Products: June 2020
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Report: AU-3S Africa focused Report on Safety Data of COVID-19 related Products: June 2020

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Report: AU-3S Africa focused Report on Safety Data of COVID-19 related Products: June 2020

Safety is a fundamental human right, however, in Africa, access to safe medical products continues to be elusive. According to the WHO Global Surveillance and Monitoring System 42% of the 1,500 reported cases of substandard and falsified medical products between 2013 and 2017 were from the Africa region. High demand during the COVID-19 pandemic has provided opportunity for counterfeit and substandard medications and critical medical supplies, such as hand sanitizers and face masks, to flood the world market, hence there is a crucial need for surveillance and prioritization of safety. The seventieth World Health Assembly (WHA 70, 2017), adopted the definitions of three classes of medical products that qualify as Substandard and Falsified (SF) Medical Products. Substandard medical products also called "out of specification", are authorized medical products that fail to meet either their quality standards or their specifications, or both. Unregistered/unlicensed medical products are those medical products that have not undergone evaluation and approval by the national or regional regulatory authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation. Falsified medical products are products that their identity, composition or source is deliberately/fraudulently misrepresented