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Global Health Econ Sustain Fast-track drug approvals in Brazil

conducting Phase III clinical studies is not feasible, is 30 days, extendable for an additional 30 days on
acceptance may be granted if there is demonstrated high justification.
therapeutic or preventive efficacy and no comparable For our study, in February 2023, we requested
therapy or alternative drug exists for that disease (Brasil, information regarding the quantity and the medications
2017a). Resolução RDC n° 204, de 27 de Dezembro de that were registered under the fast-track process (RDC
2017. Agência Nacional de Vigilância Sanitária (Anvisa). 204/2017 and RDC 205/2017) in Brazil from 2017 to 2022.
However, for drugs approved based on Phase II studies
or with Phase III studies still in progress, the company 2.2. Anvisa Medication Consultation Portal
must submit a commitment letter pledging to present The Anvisa Medication Consultation Portal provided
the results of the studies to Anvisa. The final approval of additional insights and data for this study. The portal offers
drug registration will be contingent on the submission of a monthly overview of the analysis queues, based on the
these results (Brasil, 2017b). Resolução RDC n° 205, de current rules applied to the historical document statuses.
28 de Dezembro de 2017. Agência Nacional de Vigilância The following information is presented within the panel:
Sanitária (Anvisa). a. Quantity of documents in the queue at the beginning
Table 1 presents a comprehensive overview of the fast- and the end of each month
track process characteristics implemented by the primary b. Median time between document entry to and exit
international regulatory agencies. Given the intricate from the queue
regulatory environment in the health-care market, our c. Quantity of documents that exited the queue within
study aims to evaluate the implications of expedited specific time intervals: Up to 90 days, between 90 and
drug registration through Anvisa in Brazil. The primary 180 days, between 180 and 360 days, between 360 and
objective of this investigation is to assess the impact of the 720 days, and over 720 days
recent drug registration legislation in Brazil, by comparing d. Monthly balance between the number of documents
the quantity of new drug registrations by Anvisa, both entering the queue and the number exiting
through regular and fast-track processes, spanning from e. Other related indicators
2017 to 2022. These indicators allow for the analysis of the current
2. Methods queue’s evolution, enabling the assessment of queue size,
trends in queue growth or reduction, and the median time
The data collection for this study involved accessing and documents spent in the queues. It is important to note that
retrieving public registration data from Anvisa through two this panel focuses on analyzing the queues based on the
primary sources: the Transparency Portal and the Anvisa current rules applied to the historical document statuses.
Medication Consultation Portal (Line, 2021). The period Therefore, the historical analysis of the queue may not
of data collection spanned from 2017 to 2022, focusing accurately represent the queue as it was presented on the
specifically on medications registered by Anvisa through Anvisa website, as the queue rules may have been different
the fast-track process, as outlined in RDC 204/2017 in the past.
(prioritization) and RDC 205/2017 (rare diseases).
2.3. Data analysis
2.1. Transparency portal The parameters of interest for this study were focused on
The Brazilian Transparency Portal, a comprehensive tool medication registration, further divided into different types
for accessing public administration information, was of registration and those falling under the purview of RDC
utilized to request data on medications registered by 204/2017 and RDC 205/2017. These specific subsets of
Anvisa. To obtain the relevant information, the following medication registration were chosen to assess the impact and
steps were followed: efficiency of the fast-track process introduced by Anvisa. By
a. Visiting the Brazilian Transparency Portal website. employing the Transparency Portal and the Anvisa Medication
b. Locating the section dedicated to “Information Consultation Portal, we were able to collect a comprehensive
Request” or a similar option. dataset that provided insights into the registration process for
c. Completing the required form with detailed medications, including the analysis duration and the volume
specifications regarding the requested data. of requests received and processed by Anvisa.
d. Submitting the information request electronically For the analysis of the collected data, linear regression
through the portal. was chosen as the statistical method. Linear regression
e. The information request is processed by Anvisa is a widely used technique in data analysis that allows for
analysts, and they have a deadline for a response the examination of the relationship between a dependent

Volume 1 Issue 2 (2023) 4 https://doi.org/10.36922/ghes.0995