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Global Health Econ Sustain Fast-track drug approvals in Brazil

minimal risk to the population (Martin & Shenfield, 2016; and efficacy. Through this innovative approach, Health
Mayer-Hamblett & VanDevanter, 2020). Canada ensures that Canadians have access to potentially
The accelerated registration of drugs is a procedural life-saving treatments while steadfastly upholding the
mechanism enabling the expeditious assessment and primacy of patient safety and well-being (Canada, 2002).
endorsement of pharmaceuticals deemed safe and Anvisa is entrusted with the responsibility of regulating
efficacious in the treatment of severe or life-threatening the production, distribution, and utilization of health-
conditions. This process facilitates swifter patient access care products in Brazil. This encompassing role entails the
to novel compounds with potential life-saving attributes. registration of pharmaceuticals and various other consumer
To qualify for accelerated registration, a drug must fulfill products, among others. Anvisa’s drug registration process
specific criteria, including the demonstration of efficacy, typically entails the submission of a registration request
safety, or the ability to address an unmet medical necessity. by the drug manufacturer, accompanied by substantiating
The precise set of criteria for accelerated registration may data regarding safety and efficacy. Anvisa critically assesses
vary contingent on the regulatory agency accountable for the request and determines whether the drug satisfies
evaluating and approving the drug (Gammie et al., 2015; the registration criteria. If it does, Anvisa proceeds with
Mayer-Hamblett & VanDevanter, 2020). a comprehensive review of the data and information
provided by the manufacturer. On completion of the
In the United States, the FDA employs four modalities
for expediting the registration process of drugs. These process, Anvisa grants approval for the drug to enter the
Brazilian market. Furthermore, additional overarching
modalities include Priority Review, Breakthrough criteria for drug approval may include an evaluation of its
Therapy, Accelerated Approval, and Fast Track. Under the potential impact on public health and the availability of
Priority Review modality, the FDA adheres to a 6-month
timeframe, which is significantly shorter than the standard alternative treatments for the same condition (ANVISA,
review period of 10 months (Commissioner, 2018). 2022b).
In 2016, the regulatory decision (Law No. 13.411)
The European Medicines Agency (EMA) serves as the
regulatory authority accountable for the assessment and served as a pivotal moment for expediting the registration
process of new drugs based on their priority status. The
authorization of pharmaceuticals within the European process could proceed through either the regular track or
Union. The EMA incorporates the Committee for Medicinal the priority track, depending on the criteria of technical
Products for Human Use (CHMP) and introduces two complexity, as well as the clinical, economic, and social
methodologies to expedite patient accessibility to novel benefits associated with the drug. The timeframe for
therapies: Accelerated assessment and conditional assessing priority drugs was set at 180 days. This category
marketing authorization (EMA, 2018).
includes, for example, drugs for rare diseases. Conversely,
In 2016, the Australian government made an drugs deemed non-priority must receive approval within
announcement regarding the establishment of two new 365 days (Brasil, 2016).
pathways by the Therapeutic Goods Administration for In 2017, the introduction of a new legislation, RDC 204,
the expedited approval of therapeutic advancements with prioritized petitions for registration, post-registration, and
potential life-saving capabilities. These pathways include prior consent in clinical research on medications based on
the priority review pathway and the provisional approval public relevance. The aim was to ensure and expand access
pathway (Bootes et al., 2019; Nash, 2016).
to pharmaceutical assistance. Furthermore, RDC 205, also
Health Canada, the regulatory authority for drug published in 2017, established a specialized procedure
registration in Canada, possesses a Priority Review process for obtaining clinical trial consent, certification of good
that bestows accelerated status on new drug submissions. manufacturing practices, and registration of new drugs
This expeditious review system assigns eligible requests intended for the treatment, diagnosis, or prevention of
a target review timeline of 180 days, significantly shorter rare diseases. Its objective was to expedite the registration
than the standard 300-day review period designated for process for drugs targeting rare diseases and to support
non-priority submissions. Furthermore, Health Canada actions for streamlining bureaucracy, enhancing public
has implemented the Notice of Compliance with conditions administration efficiency, and increasing manufacturers’
pathway, which facilitates the conditional approval of accountability. This ordinance maintains the requirements
drugs based on limited evidence. This pathway allows for for demonstrating quality, safety, and efficacy. However,
the timely availability of certain medications exhibiting it allows for the acceptance of safety and efficacy reports
promising therapeutic benefits, albeit necessitating further when accompanied by completed Phase II studies and
data collection and evaluation to substantiate their safety ongoing Phase III studies. Alternatively, in cases where

Volume 1 Issue 2 (2023) 3 https://doi.org/10.36922/ghes.0995