The CECMED Office of Innovation: A Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach

Abstract

Regulatory agencies across the Latin American region have strengthened their activities through the development of new regulatory science-based tools, standards and other approaches to evaluate and assess the safety, efficacy, quality and performance of therapeutics and devices. These processes have been implemented to promote the development and authorization of innovative new drugs and technologies, which pose a challenge to even well-established regulatory frameworks. Furthermore, in today's environment, the regulatory framework to protect public health can create barriers to marketing entry of novel drugs and medical devices. This article describes the pioneering approach that the Cuban regulatory agency (CECMED) has developed with the aim of building a comprehensive regulatory framework geared to accelerated innovation and enable successful transition of novel products from research and development to clinical practice. The Office of Innovation recently established at CECMED is the first flagship initiative of this type in Latin America and the Caribbean region. Its goal is to serve a leading role as a driving force for national and regional biopharmaceutical innovation. Herein, we discuss the conceptualization and management of the Office from the Latin American regional and national Cuban contexts.

The Role of Regulatory Sciences from the Perspective of the Cuban Medicines Regulatory Agency: The Impact of COVID-19 in Promoting Innovation, Cooperation and Scientific Thinking

“…This is a key step to enable patients' early access to innovative medicines. [2] The leading role of the Office of Innovation of the CEC-MED is to serve as a driving force supporting biotechnology and pharmaceutical innovation in Cuba (prospectively, the Latin American region,) positively influencing and promoting regulatory support from early stages of research projects, defining specific needs and regulatory gaps, guiding and strengthening product development strategies. In today's rapidly evolving scientific environment, innovation based on scientific regulatory approaches is essential, as well as recognizing the importance of collaboration between regulators and key stakeholders during the design, the research and development stages of novel product candidates.…”

“…On one hand, we are clearly witnessing the emerging potential of innovative medicines, therapies and technologies to help advance population health and quality of life. These innovative products can provide effective treatment for a specific illness with significant improvement over existing treatments or providing a verifiable therapeutic option for diseases where there is no effective treatment or in a subgroup of patients with unmet medical needs [2].…”