Gorry C

Language: English
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Page: 8-10
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Cuba’s nascent biotechnology sector began making scientifi c breakthroughs in the 1980s, including the isolation of human leukocyte interferon alpha (1981) and the development of the world’s fi rst safe, effective meningitis BC vaccine (1989). With positive results in hand and a growing R&D pipeline, the island nation established a national regulatory authority (NRA) to implement and oversee best practices for all pharmaceuticals and medical devices, domestically produced and imported, used in the country’s universal health system. Founded in 1989, Cuba’s Center for State Control of Medicines and Medical Devices (CECMED) is the entity charged with regulating all phases of scientifi c innovation for health, from clinical trial design to postmarketing surveillance.