Regulatory flexibilities for assuring timely access to medical products during COVID-19 Pandemic

Abstract

Introduction: The Regulatory Authorities of Medical Products have the social responsibility of the opportune access of these products to the health systems. The greatest challenge is constituted by health emergencies, for which case the traditional evaluation and authorization pathways are not designed.

Objective: To identify the regulatory changes introduced by the Center for State Control of Medicines, Equipment and Medical Devices, in response to the needs imposed by the COVID-19 pandemic, its bases, contextualization and implementation with key actions.

Methods: Longitudinal and descriptive study of the approved and current regulations, new and modified promulgated and implemented between March 2020 and October 2022. Public information was used.

Results: Eight legal documents were identified that empower the authority to exempt products and processes in special situations from compliance with the established requirements. The main characteristic of the national context was the strong state research biopharmaceutical industry, which added more complexity to the work. Four guides from the World and Pan American Health Organizations were referents. Fifteen regulations were developed and implemented with 143 regulatory actions were verified.

Conclusions: The National Regulatory Authority of Cuba, by updating and implementing the regulations with the necessary flexibilities, plays an active role in the national strategy to confront the health crisis caused by COVID-19, contributing to the timely availability of vaccines and other medical products with Assured quality for prevention and treatment, with a positive impact on the control trend of the current pandemic.