Departamento de Administração e Planejamento em Saúde, Escola Nacional de Saúde de Saúde Pública Sergio Arouca (ENSP), Fundação Oswaldo Cruz (Fiocruz). R. Leopoldo Bulhões 1480, 7º andar, Manguinhos. 21041-210 Rio de Janeiro RJ Brasil.
Faculdade de Medicina, Universidade de São Paulo. São Paulo SP Brasil.
Cien Saude Colet. 2021 Oct;26(10):4693-4702. doi: 10.1590/1413-812320212610.11472021. Epub 2021 May 28.
The SARS-CoV-2 pandemic has brought challenges related to prevention, protection and care. Coping strategies, such as social distancing, individual protection for the population and workers, increase in the number of intensive care beds, provision of human resources and equipment are necessary actions. However, there are yet no specific effective and safe medicines that justify their use. The challenge imposed on the regulatory framework for medicines is aimed at providing timely access to medicines capable of modifying the course of the disease and leading to better treatment outcomes, with health safety. Regulatory agencies must protect the health by assessing the actual benefits and harms of the medicines under these specific conditions. The article discusses the main regulatory challenges and response of regulatory agencies to the demands imposed by the COVID-19 pandemic, especially, drug development strategies and regulatory strategies related to off-label use. Emergency drug use authorization and alternatives for extended/compassionate use are addressed, as well as clinical trials, safety assessment and monitoring of adverse events.
SARS-CoV-2 大流行带来了与预防、保护和护理相关的挑战。应对策略，如保持社交距离、为民众和工作人员提供个人保护、增加重症监护床位、提供人力资源和设备，都是必要的措施。然而，目前还没有具体的有效和安全的药物来证明其使用的合理性。对药品监管框架提出的挑战旨在提供及时获得能够改变疾病进程并导致更好治疗结果的药品，同时保障健康安全。监管机构必须通过评估这些特定条件下药品的实际获益和危害来保护健康。本文讨论了主要的监管挑战以及监管机构对 COVID-19 大流行所带来的需求的应对措施，特别是与药品的标签外使用相关的药物开发策略和监管策略。本文还讨论了紧急用药授权以及扩大/同情用药的替代方案，以及临床试验、安全性评估和不良事件监测。
