CURRENT REGULATORY TRENDS IN THE CUBAN BIOTECHNOLOGY INDUSTRY

Abstract

Significant advancements in the global biotechnology industry, including gene therapy, artificial intelligence, nanotechnology, 3D bioprinting, and environmental biotechnology, establish challenges in complying with current regulations. Cuban biotechnology, as a leader in innovation and sustainability, must adopt current regulatory trends in order to access international markets with products of high added value. This approach contributes to the country's economy and allow raising the health levels of the Cuban population. This paper highlights how the Center for Genetic Engineering and Biotechnology (CIGB) updated its regulatory management to align with trends set by national regulatory authorities: regulatory flexibility, greater transparency in decision-making and global harmonization. This effort focusses on addressing health emergencies, enhancing quality of life and developing agricultural projects for food production. Methods including reviewing regulatory agency guidelines for biomedical and veterinary medicines, analyzing recent scientific publications and conducing gap analyses. The results identified challenges in the biotechnology product approval process and outlined actions to achieving new registrations for biopharmaceuticals and certifications for agricultural biotech products. The CIGB demonstrated its alignment with current trends, showcasing its commitment to innovation and sustainability.