Preprint Article Version 1 This version is not peer-reviewed

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

Version 1 : Received: 17 September 2019 / Approved: 18 September 2019 / Online: 18 September 2019 (12:51:16 CEST)

How to cite: Romeu, B.; Perez Cristiá, R. The Office of Innovation: As Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach. Preprints 2019, 2019090204 (doi: 10.20944/preprints201909.0204.v1). Romeu, B.; Perez Cristiá, R. The Office of Innovation: As Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach. Preprints 2019, 2019090204 (doi: 10.20944/preprints201909.0204.v1).

Abstract

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.

Subject Areas

Office of Innovation; novel drugs; novel therapies; regulatory science; Latin American Regulatory landscape

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