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

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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.

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Acknowledgements

We gratefully acknowledge Dr. Silvia Bendiner and Professor Javier Eduardo Vázquez for their helpful discussions and constructive comments on the manuscript. The authors are also grateful to Prof. Lawrence Liberti for critical reading of the manuscript.

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  1. Center for State Control of Drugs, Equipment and Medical Devices (CECMED), Innovation Office, Calle 5ta A #6020 e/60 y 62. Miramar, Playa. Código Postal 11300, Havana, Cuba

    Belkis Romeu PhD & Rafael Perez Cristiá MD, PhD

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  1. Belkis Romeu PhD
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  2. Rafael Perez Cristiá MD, PhD
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Correspondence to Belkis Romeu PhD or Rafael Perez Cristiá MD, PhD.

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Romeu, B., Perez Cristiá, R. The CECMED Office of Innovation: A Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach. Ther Innov Regul Sci 55, 163–169 (2021). https://doi.org/10.1007/s43441-020-00202-7

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