Cuba's nascent biotechnology sector began making scientific breakthroughs in the 1980s, including the isolation of human leukocyte interferon alpha (1981) and the development of the world's first 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 scientific innovation for health, from clinical trial design to postmarketing surveillance.
Dr Rafael Pérez Cristiá, Distinguished Member of the Cuban Academy of Sciences, has been Director General of CECMED since 2000, overseeing regulation and control of unique and innovative biotechnology products and the concomitant evolution of the nation's regulatory authority. Under his guidance, CECMED has regulated unique therapies, vaccines, and pharmaceutical products—some unavailable anywhere else in the world—aimed at improving population health both at home and abroad. Recognized internationally as one of the top 20 countries with a safe and reliable biotechnology industry and regulatory authority, Cuba is having a measurable impact on public health. In this exclusive interview, Dr Pérez Cristiá, explains how a small,
resource-scarce country has rocketed into the global biotech elite—and how it intends to stay there.
http://www.medicc.org/mediccreview/index.php?issue=45&id=612&a=va