Citation

Oliveira CVDS, Pepe VLE. Cien. Saude Colet. 2024; 29(7): e03442024.

Copyright

(Copyright © 2024, Associacao Brasileira de Pos-Graduacao em Saude Coletiva)

DOI

10.1590/1413-81232024297.03442024

PMID

38958323

Abstract

Public Health Emergencies (PHE) have had repercussions on health systems on a global scale, and timely access to new health technologies is a challenge for health policy. The national regulatory authorities (NRA) play a key role in the evaluation and regulation of these technologies. The present study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the health system's effective response 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 also identified in order to implement new ones.

Language: en

Keywords

Humans; *Public Health; Brazil; World Health Organization; International Cooperation; *Emergencies; *Health Policy; Biomedical Technology/legislation & jurisprudence; Delivery of Health Care/organization & administration/legislation & jurisprudence