Advancing Biopharmaceutical Innovation and Patient Access: Call to Action for Latin American Regulators


Writing in the August edition of DIA’s Global Forum magazine, Silvia B. Bendiner of WESSX Inc. and Belkis Romeu call for greater regulatory collaboration between Latin American countries, building on an initiative created by Dr. Rafael Pérez Cristiá at the Cuban Regulatory Authority (CECMED).


The need for further regulatory convergence and collaboration among regulators in Latin America remains an urgent topic. This article advances this discussion by expressing the strategic vision and professional legacy of Dr. Rafael Pérez Cristiá, a leading advocate for strengthening the region’s medicines regulatory systems. It also proposes how regulators in Latin America can leverage an initiative envisioned during his three-decade tenure as head and director of the Cuban Regulatory Authority (CECMED) and support advancing healthcare innovation in the region through knowledge sharing and training in regulatory sciences.


CECMED’s Office of Innovation

The Cuban Regulatory Authority is one of the regulatory bodies recognized by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr). In addition to Cuba, this NRAr Group consists of the National Administration of Drugs, Food and Medical Devices (ANMAT) of Argentina, the National Health Regulatory Agency (ANVISA) of Brazil, the National Institute of Drug and Food Surveillance (INVIMA) of Colombia, the Public Health Institute (ISP) of Chile, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) of Mexico, Health Canada, and the US Food and Drug Administration (FDA). This designation of these authorities, based on a Resolution of PAHO’s Directing Council, is a recognition of their leadership in regulatory capacity in the region.

This designation is also linked to the NRAr’s commitment to actively promoting the exchange of information on the regulation of medicines and other health technologies, thus strengthening other national regulatory partners. Aware of its role as a regional reference, CECMED has historically worked with regulators throughout the Caribbean, Latin America, and the rest of the world to build processes and systems that contribute to transforming the effectiveness and efficiency of regulatory agencies and facilitating their ability to ensure timely access to quality, safe, and effective therapies, including innovative medicines.

Under Dr. Pérez Cristiá’s leadership, CECMED established an Office of Innovation in 2019. The goal of this flagship initiative, the first of its type in Latin America and the Caribbean, is to serve as a driving force for national and regional biopharmaceutical innovation. This office was created with the goal of building regulatory capacity and implementing regulatory science tools as well as good regulatory practices, while considering the budgetary constraints and resource limitations of Cuba’s economy. In its strategic framework, scientific innovation is assessed by dedicated teams of researchers, clinicians, and (both national and global) regulatory assessors in tandem with the Cuban industry association BioCubaFarma, supported by the advice of local and global experts. These parties collaborate with this Office of Innovation to consolidate shared risks and strategies during development of innovative products, guaranteeing safe and efficacious alternatives to counteract life-threatening diseases and public health emergencies, and conveying a positive and direct impact on the Cuban population.


Call for Action to Regulators in Latin America

This example from Cuba can be of great use to other Latin American NRAr, fostering innovation and regional access to novel effective therapies, based on lessons learned during and after the COVID-19 pandemic. Within the framework of a globalized approach to regulatory alignment, and on the basis of the above initiative in Cuba, the authors wish to bring the new pilot project described herein to the attention of, and for consideration by, the NRAr and other regional health stakeholders.


Read the full article on the DIA Global Forum website here

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