Page 32 - GHES-1-2

Global Health Econ Sustain

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

Volume 1 Issue 2 (2023) 1 https://doi.org/10.36922/ghes.0995