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P234: Regulatory Updates: New Therapeutic Possibilities for the Brazilian Population

Poster Presenter

Renata Costa

Specialist
Libbs Farmaceutica
Brazil

Objectives

The aim is to highlight the role of Medical Affairs in the context of a new regulatory paradigm established by the Brazilian regulatory agency ANVISA, which now allows to request approval of innovative drugs using scientific literature by a Systematic Review to demonstrate safety and efficacy.

Method

Assessing the latest Brazilian regulation concerning drug development and examining relevant literature to create a novel process for the development of new drugs in Brazil. It seeks to identify and confirm the necessary criteria for this process in collaboration with the regulatory authority.

Results

Recent studies have highlighted the disparities in drug development across different economic regions, revealing that about 90% of clinical trials and over 80% of their participants are concentrated in high-income countries. This imbalance underscores the challenges faced by Brazil, where regulatory processes are notably protracted, ranking among the slowest in Latin America. A comparative analysis with 9 other Latin American countries showed that the studies approval and patient recruitment in Brazil lagged by an average of 11 months. This delay emphasizes the critical need for a more efficient drug development. In response, ANVISA's Regulation No.753, enacted in 2022, introduced a new framework for drug submission, either through complete or shortened development pathways. This adjustment aims to align Brazil's process more closely with international standards set by bodies such as the US Food and Drug Administration and the European Medicines Agency. This regulation offers a streamlined pathway for the approval of synthetic or semi-synthetic drugs that have been on the global market for over a decade. It allows for the use of data from robust scientific literature as evidence of a drug's safety and efficacy through a Systematic Review based on PRISMA guideline. To support this, a new workflow was established in Medical Affairs and related areas, focusing on regulatory intelligence analysis from the earliest stages of project development. This involves assessing the availability and quality of nonclinical and clinical data to support a Systematic Review and selecting a primary medicine for extrapolation studies, which may vary from relative bioavailability study to more specific clinical trial. Numerous adjustments were implemented to assess new activities, financial implications, potential risks and timelines, leading to an increase in both the speed and quantity of submissions. Collaborations were established with researchers across various medical specialties.

Conclusion

In conclusion, given that Brazil has one of the lengthiest regulatory timelines in Latin America, the implementation of a novel regulatory framework by ANVISA, which allows for the submission of innovative medicines using scientific literature for evidence of safety and efficacy, has significantly transformed the landscape of drug development in Brazil. This approach has fostered better communication between researchers and the industry, leading to the harmonization of regulatory documents and the generation of new, globally accessible scientific publications. The interaction has also enriched the Medical Affairs team's understanding of statistical methods and systematic reviews, boosting the strategic positioning of this area within the company. Moreover, this pathway has facilitated learning in key strategic areas, such as product feasibility and regulatory affairs, leading to the refinement of project evaluation processes and the creation of new standard operating procedures. Importantly, this regulatory innovation aligns with ethical considerations by reducing the need for redundant animal and human studies when existing data are already robust and well-established. Ultimately, this novel pathway accelerates patient access to new medications, ensuring a more equitable distribution of medical advancements across the Brazilian population.