Assessing the impact of fast-track drug registration by Anvisa in Brazil: A descriptive study of new drug registrations from 2017 to 2022

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 afford 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 effectiveness 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 financing 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 effectiveness 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 offer a sustainable alternative for health-care systems.