0194/2021 - COVID-19 e os desafios para a regulação de medicamentos em tempos de pandemia COVID-19 and the challenges for medicines regulation in times of pandemics
A pandemia de SARS-CoV-2 trouxe desafios relacionados à prevenção, proteção e cuidado. Estratégias de enfrentamento, como distanciamento social, medidas de proteção individual da população e trabalhadores, ampliação dos leitos de terapia intensiva, disponibilização de recursos humanos e equipamentos são ações necessárias. Não há, ainda, medicamentos específicos com eficácia e segurança que justifiquem sua utilização. O desafio imposto ao marco regulatório de medicamentos volta-se para o acesso tempestivo a medicamentos capazes de modificar o curso da doença e conduzir a melhores desfechos no tratamento, com segurança sanitária. Cabe às agências reguladoras a proteção da saúde com a atribuição de avaliar os reais benefícios e malefícios dos medicamentos nestas condições especificas. O artigo apresenta as ações das agências reguladoras e discute os desafios na implementação da política regulatória de medicamentos frente às exigências impostas pela pandemia de Covid-19. São abordadas, especialmente, estratégias de desenvolvimento de fármacos e estratégias regulatórias sobre a indicação de uso off label, do uso emergencial de medicamentos e das alternativas de uso extendido/compassivo, bem como da realização de ensaios clínicos e da avaliação da segurança e monitoramento de eventos adversos.
The SARS-CoV-2 pandemic brought challenges related to prevention, protection and care. Coping strategies, such as social distancing, individual protection for the population and workers, increase in number of intensive care beds, provision of human resources and equipment are necessary actions. There are no specific medicines with efficacy and safety that justify their use. The challenge imposed on the regulatory framework for medicines is 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 health by assessing the real benefits and harms of medicines under these specific conditions. The article discusses the main regulatory challenges and response of regulatory agencies to the demands imposed by Covid-19, especially, drug development strategies and regulatory strategies related to off-label use, emergency use authorization of medicines and alternatives for extended / compassionate use are addressed, as well as clinical trials, safety assessment and adverse events monitoring.
Keywords:
Covid-19, Pharmaceutical Preparations, Pandemics, Health Surveillance
COVID-19 and the challenges for medicines regulation in times of pandemics
Resumo (abstract):
The SARS-CoV-2 pandemic brought challenges related to prevention, protection and care. Coping strategies, such as social distancing, individual protection for the population and workers, increase in number of intensive care beds, provision of human resources and equipment are necessary actions. There are no specific medicines with efficacy and safety that justify their use. The challenge imposed on the regulatory framework for medicines is 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 health by assessing the real benefits and harms of medicines under these specific conditions. The article discusses the main regulatory challenges and response of regulatory agencies to the demands imposed by Covid-19, especially, drug development strategies and regulatory strategies related to off-label use, emergency use authorization of medicines and alternatives for extended / compassionate use are addressed, as well as clinical trials, safety assessment and adverse events monitoring.
Palavras-chave (keywords):
Covid-19, Pharmaceutical Preparations, Pandemics, Health Surveillance
Pepe, V. L., Novaes, H. M. D., Osorio-de-Castro, C.G.S. COVID-19 e os desafios para a regulação de medicamentos em tempos de pandemia. Cien Saude Colet [periódico na internet] (2021/Jun). [Citado em 06/07/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/covid19-e-os-desafios-para-a-regulacao-de-medicamentos-em-tempos-de-pandemia/18093?id=18093
