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Global Health Econ Sustain Fast-track drug approvals in Brazil

under RDC 204/2017 and RDC 205/2017. By applying linear time of 611 days and a minimum time of 58 days, with a
regression to the dataset, we can determine the significance median duration of 176 days. Similar to the previous result,
and strength of these relationships and analyze the trends the linear regression analysis demonstrates a significant
in the registration process over the period from 2017 to trend of decreasing average of queue length, supported by
2022. Furthermore, linear regression allowed us to establish p < 0.0000001 (95% confidence interval).
a trend line that represents the overall pattern of the analysis The analysis focused on the queue of finalization time
duration and provides insights into the efficiency and impact for drug registration through prioritization (RDC 204/2017)
of the fast-track process introduced by Anvisa. The p-values and/or rare diseases (RDC 205/107) presented in Figure 4.
obtained from the linear regression analysis were used to The maximum length of time observed was 120 days, with
assess the statistical significance of the relationships and an average of 15 days. However, it should be noted that these
95% of confidence intervals were determined to estimate
the precision and uncertainty associated with the estimated resolutions have just been recently implemented, resulting
regression coefficients. in limited data availability for calculating the median. This
limitation stems from the fact that the dataset used for the
3. Results analysis comprised a relatively small sample size, which may
not adequately represent the entire population of registrations.
The data retrieved from the Anvisa transparency portal Despite these limitations, a linear regression analysis was
revealed a noteworthy increase in the number of fast-track conducted to explore any potential trends in the average
requests, from just one in 2018 to 32 in 2021. Furthermore, registration time. The regression analysis revealed a slight
in the year of 2022, a total of 40 fast-track registrations upward trend, indicating a potential increase in the average
were made (Figure 1). time required for registration. Notably, the p-value associated
Figure 2 displays the queue finalization time for with this trend was calculated to be p = 0.054 (95% confidence
medication-related requests. The analysis revealed a interval), suggesting a statistically significant relationship
maximum time of 548 days and a minimum time of between time and the registration process. However, it is
73 days, with a median duration of 159 days. Notably, a important to interpret this p-value with caution, as the limited
linear regression analysis showed a significant trend of data available may have influenced the statistical analysis.
decreasing average finalization time, corroborated by
p < 0.001 (95% confidence interval). 4. Discussion

Figure 3 illustrates the queue time until finalization for The data obtained in this study from the Anvisa
medication registration. The analysis indicates a maximum Transparency Portal highlight a significant rise in fast-

Figure 1. Fast-track registrations by Anvisa.

Volume 1 Issue 2 (2023) 6 https://doi.org/10.36922/ghes.0995