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. Preprints2019, 2019090204. https://doi.org/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. https://doi.org/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. Preprints2019, 2019090204. https://doi.org/10.20944/preprints201909.0204.v1
APA Style
Romeu, B., & Perez Cristiá, R. (2019). The Office of Innovation: As Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach. Preprints. https://doi.org/10.20944/preprints201909.0204.v1
Chicago/Turabian Style
Romeu, B. and Rafael Perez Cristiá. 2019 "The Office of Innovation: As Core Initiative to Bolster Novel Pharmaceutical Products-The Cuban Approach" Preprints. https://doi.org/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.
Keywords
Office of Innovation; novel drugs; novel therapies; regulatory science; Latin American Regulatory landscape
Subject
Public Health and Healthcare, Health Policy and Services
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
