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.

Regulatory agencies across the Latin American Region have strengthened the regulatory science through the development of new tools, standards and various other related parameters to evaluate and assess safety, efficacy, quality and performance. The former have been implemented to promote and incorporate new drugs and technologies, which still, are a challenge to well-established regulatory frameworks. Furthermore, in today’s environment, the existing regulatory framework protecting public’s health creates barriers for market entry of novel drugs and medical devices. This article aims to the pioneering work that Cuban Regulatory Agency (CECMED) has been developing with the aim to build a strong regulatory framework geared to accelerated innovation and the successful transition from research and development to clinical development. The Office of Innovation recently established at the CECMED is the first flagship in Latin America and the Caribbean region. Its aim is to play a leading role as a driving force for the national and regional biopharmaceutical innovation. This article will discuss the Office of Innovation its conceptualisation and management taking into account the Latin American regional and national Cuban context.