Viktoria Magyar
University of Southern California

riven by increasing workloads, limited medical supplies and expertise, and technological advancements, global healthcare systems underwent serious transformation during the pandemic. The World Health Organization (WHO) initiated the development of guidelines for good regulatory practices (GRP) to support higher quality controls, improve decision-making, and produce better public health outcomes during the pandemic.

Challenged by regulatory convergence initiatives and collaborative registration procedures, Latin America’s regulatory agencies (such as Cuba’s CECMED [see below]) and other agencies around the world prioritized and resourced accelerated review processes that satisfied public expectations to meet mandated vaccination and related COVID-19 healthcare goals. Implementation of risk-calibrated pre-market approval with enhanced post-authorization surveillance, and acceptance of clinical evidence from overseas and real-world data (instead of duplicating all efforts locally), proved essential. Regulatory reliance and harmonization platforms that shared information for synchronized decision making; recommendations for implementation of an abridged pre-qualification review process to optimize regulatory review; development of IMDRF guidance for internationally harmonized emergency regulatory mechanisms; and the availability of a greater variety of point-of-care and at-home testing resources, aligned in terms of interagency regulation; all worked together to enable global supply resilience and improved access to a broad portfolio of testing technologies. The continued practice of regulatory agility during and beyond the pandemic was also deemed crucial.

Capacity limitations exacerbated other pandemic challenges. Several of Latin America’s regulatory authorities had no digital health (DH) systems to depend on during societal lockdowns or struggled to consistently perform core agency functions due to nonpandemic work being backlogged.

Adopting fit-for-purpose regulations that meet the needs of these DH technologies and using these technologies to expand pre- and post-market capabilities will also increase resource capacity. For example, digital tools can help alleviate registration backlogs and enable eLabeling and remote or virtual inspections.

Ensuring access to new generations of products and rapidly growing innovation is critical in the pandemic’s wake. Countries that adopt regulatory agility-reliance models, or apply emergency use pathways and exemptions, will lead the way to faster access to novel therapeutics, medical instruments, and innovative digital health technologies, improving healthcare outcomes for patients in Latin America and all around the world.

Cuba’s response to COVID-19 is arguably a model for building capacity and preparing for future pandemics. In a virtual conference that shared the regulatory agency and pharmaceutical industry reactions to the pandemic in Cuba, and simultaneously previewed similar topics planned for discussion at DIA’s Latin America Regulatory Conference, the director of CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos/Center for State Control of Medicines and Medical Devices) overviewed the regulatory processes that Cuba used to ensure comprehensive and independent solutions to this global health crisis and the innovators behind Cuba’s own vaccine candidates.

CECMED refined its regulatory framework through 15 new legal provisions that helped accelerate the development, review, and approval of COVID-19 therapies and vaccines, including five vaccines developed in Cuba. This accelerated evaluation process includes acceptance of overlapping study phases, partial reporting, adapting the style of information packages to reflect the data (e.g., stability data) presented at that specific development stage, and benefit-risk analyses in the specific context of the pandemic.

Approximately 10 million Cubans, or 88% of the population, have received 34 million vaccine doses and nearly 5.4 million booster shots. Cuba’s vaccines have consistently demonstrated an adequate safety profile and have been well-tolerated after millions of doses were administered to both adults and children. Overall, vaccinated individuals have exhibited minor reactogenicity and good tolerability, and the safety profile has shown a predominance of mild local adverse reactions. One vaccine has shown 92.28% efficacy in preventing symptomatic forms of the disease. The heterologous vaccination schedule of a second vaccine, with two doses and then a third follow-up booster, has demonstrated 91.2% overall efficacy in disease prevention. The demonstrated benefits of both vaccines have played a major role in controlling the epidemic in Cuba.

The complementary industry perspective calls for leadership in every community of stakeholders (industry, regulators, patients, providers, payers, etc.) to embrace these lessons by continuing to optimize regulatory and industry practices after the pandemic has subsided.

The author wishes to thank Directora Olga Lidia Jacobo-Casanueva (CECMED) and Duglas Rodriquez Calderon (Roche Diagnostics) for their contributions to this report. To learn more, plan to attend our Latin America Regulatory Conference, March 14-16.