Brazil's Regulatory Transformation: A New Era For Clinical Development
A conversation between Renato Porto, President, Interfarma, and Former Director, ANVISA, and Clinical Leader Executive Editor Abby Proch
Brazil is on the come-up. If you’ve tracked evolving regulatory frameworks around the world, you’ll know that Brazil enacted a new clinical research law in 2024 and issued its implementing decree in 2025, giving the country a new direction in global clinical development.
Coming off the conversations at September’s “Clinical Development in LATAM: Brazil Unlocked,” this Q&A series examines what those changes mean in practice for global clinical research organizations.
This first installment features Renato Porto, president of Interfarma and former director of ANVISA. He explains why sponsors increasingly recognize Brazil’s scale, diversity, investigators, and scientific capabilities, even as outdated perceptions of bureaucracy persist.
Clinical Leader: Based on your conversations at the event, how do global sponsors and research leaders currently perceive Brazil’s clinical research environment?
Renato Porto: The perception is positive regarding Brazil’s potential, with significant room for further growth in terms of execution. Global sponsors recognize Brazil’s strong structural advantages: a large population, ethnic diversity, a high prevalence of different diseases, a large-scale healthcare system, qualified investigators, and well-established scientific capabilities.
At the same time, Brazil is still often associated with a historical perception of long approval timelines, complex ethical review processes, regulatory unpredictability, and operational challenges in activating research sites and recruiting patients.
However, this perception is beginning to change. The data presented by Interfarma and IQVIA at the event provide a concrete indication of this shift, with Brazil achieving a stronger position in the global ranking of newly initiated clinical trials in the first half of 2026 compared with the same period over the previous five years. This suggests that recent regulatory advances are beginning to translate into actual decisions to allocate clinical trials to Brazil.
Therefore, the international perception of Brazil’s clinical research environment has not yet fully caught up with the pace of recent regulatory changes. The challenge is no longer only to reform the system, but also to demonstrate globally that the system has changed.
How accurate is that perception, after the new Clinical Research Law, and what misconceptions would you like to correct?
Brazil should no longer be perceived as an excessively bureaucratic environment. Law No. 14,874/2024 and its subsequent regulation have brought greater legal certainty, clear timelines, and stronger alignment with international good practices.
There are now clearly defined timelines for both ANVISA and the ethical review system. The ethical review framework has been centralized under the National Research Ethics Authority (INAEP), helping to reduce duplication and streamline the review process.
At the same time, the legislation maintains robust protections for clinical trial participants, comparable to those in leading clinical research countries.
What do you see — or did attendees identify — as the most important early evidence that the new law and modernization efforts are improving predictability and timelines?
In the first half of 2026, Brazil achieved its best position in the global clinical trials ranking when compared with the same period over the previous five years.
Even in a context of contraction in global clinical research activity, Brazil maintained a 2.1% share of clinical trials initiated worldwide. Among the top 30 countries, Brazil recorded the largest gain in global share, excluding the United States and Australia.
These results reinforce Brazil’s resilience in the global clinical research landscape and demonstrate the country’s potential to attract more clinical trials and investment, while also expanding opportunities for Brazilian patients to access innovative therapies.
The IQVIA/Interfarma analysis forecasts Brazil moving from 20th to 10th globally in newly initiated clinical trials. What operational or policy changes appear most likely to enable that growth?
There are four changes that must happen to enable that growth:
- Fully implement the new ethical review framework. We need to translate the timelines established by law into consistent and predictable performance across the entire system. There are still transitional issues to be addressed in the regulatory framework, including the migration from the current model to the new National Research Ethics System.
- Preserve and further advance ANVISA’s modernization. Reliance, risk-based review, and convergence with international standards need to move from being exceptional mechanisms to becoming part of routine regulatory practice. ANVISA itself has recognized that RDC 945/2024 and IN 338/2024 were designed to reduce duplication and accelerate the authorization of clinical trials.
- Improve site performance and patient recruitment. There is limited value in approving a clinical trial protocol quickly if it still takes months to contract and activate a research site, or if we are unable to identify and recruit eligible patients. The more than 600,000 potential patients who were not recruited between 2020 and 2025 illustrate the scale of this opportunity. Brazil needs to further professionalize research sites, expand workforce capabilities, make better use of health data, and strengthen its ability to identify eligible patients.
- Make clinical research a strategic national policy. Competition for clinical trials is global. Brazil needs to combine its new regulatory environment with a structured policy to attract clinical trials, develop research sites, build professional capabilities, and strengthen collaboration among government, academia, healthcare providers, patients, and industry.
About The Expert:
Renato Porto is an executive with over 20 years' experience in regulated markets. He has been the CEO of Interfarma (the Brazilian Pharmaceutical Research Industry Association) since 2023.
Previously, he was a director at the National Health Surveillance Agency (Anvisa) and at the Brazilian Association of Pharmacy and Drugstore Networks (Abrafarma), where he was responsible for institutional relations.
He holds a law degree from UniCEUB and has specialised in Health Surveillance (Fiocruz), Civil Procedural Law (PUC-SP) and Health Management (MBA, FGV). He has also completed Board Member training with IBGC and received international training in Regulatory Impact Analysis at LUISS Guido Carli University in Italy.