Abstract This article examines the origins of Cuba’s biotechnology industry and its roles in supporting the Cuban national healthcare strategy and providing a framework for the country’s response to the global COVID-19 pandemic. The author also provides a brief overview of the Cuban regulatory landscape. Keywords – biotechnology, CECMED, COVID-19, Cuba, vaccine.
Background and introduction
The Cuban pharmaceutical and biotechnology industry emerged in the early 1980s after the country experienced a hemorrhagic dengue epidemic and outbreak of meningococcal disease in quick succession. The challenges presented by these events were among the key factors that spurred the redesign of existing drug regulations and the regulatory control systems to ensure greater quality assurance while mitigating risk to patient safety. The establishment of the National Regulatory Agency for Medicine (CECMED) in 1989 served as the pivotal facilitator for the implementation of a national
regulatory framework. The National Regulatory Bureau for Protection of Public Health was created in 2011 to control and manage health surveillance and broaden CECMED’s scope to include regulation and oversight of medical devices to support the healthcare system.1
The following figure shows the key regulatory milestones accomplished by the CECMED after it became the first national reference authority in the Latin American region to receive World Health Organization (WHO) qualification and certification for vaccine regulation.
