In 1987, Uchiyama defined “regulatory sciences” as the process for assessing scientific optimization and technologi- cal developments through accurate prediction, evaluation, and decision-making process, based on scientific evidence with the aim to impact human health. For the past thirty years, within the context of regulations, both for medicines and medical devices, the term regulatory sciences […]

El Dr. Pérez Cristiá fue un investigador, farmacólogo y toxicólogo de formación, académico de mérito por la Academia de Ciencias de Cuba. Ocupó varios cargos como investigador y profesor en la Universidad de Medicina de La Habana, Cuba y en la Universidad Nacional de Carabobo en Valencia, Venezuela. También ocupó diversos nombramientos científicos como Presidente

Much evidence demonstrates that pharmaceutical innovation is having a positive impact on short- and long-term improve- ments on human health. Novel drugs and/or their combina- tions, vaccines against communicable and non-communica- ble diseases (e.g. cancer, diabetes, and orphan diseases) are being introduced at an increasingly rapid pace. Furthermore, the use of the state-of the art

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

The COVID pandemic precipitated sweeping changes in established policies and practices and emphasized the confluent dynamics of disease burdens, optimized healthcare systems, and the socio-economic influences of globalization. We now stand at the crossroads of an unprecedented global challenge which demands that researchers, regulators, policy makers, and governments address multiple dimensions that go far beyond