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0061/2024 - Health policy and Regulatory Authorities: challenges of technology regulation in Public Health Emergencies
Política de saúde e Autoridades Reguladoras: desafios da regulação de tecnologias nas Emergências em Saúde Pública

Author:

• Catia Veronica dos Santos Oliveira - Oliveira, C. V. S. - <catia.oliveira@fiocruz.br>
ORCID: https://orcid.org/0000-0002-0464-1476

Co-author(s):

• Vera Lúcia Edais Pepe - Pepe, V. L. E - <vera.pepe@fiocruz.br>
ORCID: https://orcid.org/0000-0003-0606-1544


Abstract:

Public Health Emergencies (PHE) have had repercussions on health systems on a global scale. Timely access to new health technologies is a challenge for health policy. The National Regulatory Authorities (NRA) have a fundamental role in the evaluation and regulation of these technologies. The study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the response of the health system, during a PHE. This research, based on WHO and Brazilian NRA norms and documents, considered dimensions related to strategies for strengthening regulatory activities and regulatory instruments used to accelerate access to technologies, especially during PHEs. International cooperation between the NRA and the WHO were important strategies for strengthening the NRA, with emphasis on the use of reliance, regionalization, accelerated assessments and work/information sharing, as well as the processes of regulatory harmonization and convergence. In addition to the use of existing regulatory instruments, efforts were identified to implement new ones to speed up access to health technologies, with emphasis on Emergency Use Authorization.

Keywords:

Emergencies, Health Policy, International Cooperation, Health Surveillance, Brazilian Health Surveillance Agency.

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Oliveira, C. V. S., Pepe, V. L. E. Health policy and Regulatory Authorities: challenges of technology regulation in Public Health Emergencies. Cien Saude Colet [periódico na internet] (2024/Mar). [Citado em 05/11/2024]. Está disponível em: http://cienciaesaudecoletiva.com.br/en/articles/health-policy-and-regulatory-authorities-challenges-of-technology-regulation-in-public-health-emergencies/19109?id=19109



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