Volume X Issue X (2023) 1 https://doi.org/10.36922/ghes.0995 ORIGINAL RESEARCH ARTICLE Assessing the impact of fast-track drug registration by Anvisa in Brazil: A descriptive study of new drug registrations from 2017 to 2022 Marcus Carvalho Borin 1,2 *, Mariana Michel Barbosa 1,2 , Camila Oliveira Pereira 1,2 , Carina Rejane Martins 1 , Daniel Pitchon dos Reis 1 , Geraldo José Coelho Ribeiro 1,3 , Júlia Teixeira Tupinambás 1 , Karina de Castro Zocrato 1 , Lélia Maria de Almeida Carvalho 1 , Marcela Pinto de Freitas 1 , Maria da Glória Cruvinel Horta 1 , Mariza Cristina Torres Talim 1 , Ernesto Gomes de Azevedo 1 , Sergio Adriano Loureiro Bersan 1 , and Silvana Marcia Bruschi Kelles 1,3 1 Health Technology Assessment Group, Unimed-BH, Belo Horizonte, MG, Brazil 2 Faculty of Pharmacy, Federal University of Minas Gerais (UFMG). Belo Horizonte, MG, Brazil 3 Department of Medicine, Pontifical Catholic University of Minas Gerais, Betim, MG, Brazil Abstract Prompt release of novel pharmaceuticals is very much sought after during critical circumstances to aid patients and society in need. Nonetheless, the expeditious availability of these medications may jeopardize the well-structured investigations and observations. To tackle this concern, regulatory agencies globally have implemented expedited registration procedures. In Brazil, the National Health Surveillance Agency (Anvisa) has likewise implemented an expedited registration process to cater to patients who cannot aford to wait. The objective of this study is to evaluate the impact of Anvisa’s accelerated drug registration on the challenging regulatory environment in Brazil. Data pertaining to medications registered by Anvisa from 2017 to 2022 through the expedited process were procured from the Federal Government’s transparency portal and the medication consultation portal. The registration of novel drugs by Anvisa through both standard and expedited processes during this timeframe was analyzed. The introduction of the accelerated registration regulation by Anvisa in 2017 led to a substantial rise in registration requests utilizing this regulatory modality. Furthermore, the data concerning drug registration through all channels unveiled a noteworthy reduction in average response time. Despite concerns pertaining to the efectiveness and safety of drugs registered through the expedited process, often reliant on Phase II studies, the utilization of this process is on the rise worldwide, including in Brazil. To ensure the sustainability of health-care systems, it may be advantageous to implement provisional registration in conjunction with subsequent evaluation through real- world studies and fnancing based on risk-sharing agreements. In conclusion, the accelerated drug registration process implemented by Anvisa in Brazil has exhibited promising results in terms of reduced response times. Nevertheless, the efectiveness and safety of drugs registered through this process necessitate meticulous evaluation. The implementation of provisional registration and the integration of real-world studies, alongside managed entry agreements, could ofer a sustainable alternative for health-care systems. Keywords: Fast track registration; Drug approval; Anvisa; Brazil; Health-care systems Global Health Econ Sustain Academic editor: Mihajlo Jakovljevic M.D. Ph.D. MAE *Corresponding author: Marcus Carvalho Borin (marcusborin@gmail.com) Citation: Borin, M.C., Barbosa, M.M., Pereira, C.O., Martins, C.R., dos Reis, D.P., Ribeiro, G.J.C. et al. 2023. Assessing the impact of fast-track drug registration by Anvisa in Brazil: A descriptive study of new drug registrations from 2017 to 2022. Global Health Econ Sustain. https://doi.org/10.36922/ghes.0995 Received: May 25, 2023 Accepted: July 20, 2023 Published Online: August 22, 2023 Copyright: © 2023 Author(s). This is an Open Access article distributed under the terms of the Creative Commons Attribution License, permitting distribution, and reproduction in any medium, provided the original work is properly cited. Publisher’s Note: AccScience Publishing remains neutral with regard to jurisdictional claims in published maps and institutional afliations.