The new framework aims to accelerate access to medicines, attract investments, and enhance Brazil’s global competitiveness in clinical research.
A new milestone for science and innovation
The Brazilian government has enacted the new Clinical Research Law, marking a significant step toward strengthening the country’s scientific and innovation ecosystem.
The regulation provides greater legal certainty and streamlined procedures, making Brazil a more attractive destination for international research and development initiatives.
Currently ranked 20th globally in clinical research participation, Brazil is expected to rise to 10th place following the implementation of the new rules.
Economic potential and market impact
According to a study by Interfarma and IQVIA, the new law could generate BRL 2.1 billion (approx. USD 400 million) in direct annual investments, with an economic impact exceeding BRL 6.3 billion per year. Additionally, an estimated 56,000 scientific professionals could be involved in new research projects.
Brazil stands out for its cost advantages, diverse population, and qualified research centers, which strengthen its position as a strategic hub for global clinical studies.
Faster and more efficient approval processes
The new regulation significantly shortens approval timelines for clinical trials:
- From 180 to 30 days for Ethics Committees (CEPs);
- Up to 90 business days for ANVISA evaluations;
- And 15 business days for strategic or emergency public health studies.
These changes aim to make Brazil’s regulatory environment more agile, transparent, and competitive in the global R&D landscape.
A boost for innovation and collaboration
The Ministry of Health expects the new framework to double the number of clinical studies conducted in Brazil, strengthening cooperation between public institutions, private industry, and international organizations.
Beyond advancing innovation, the measure should stimulate the local pharmaceutical industry, create jobs, and expand access to innovative treatments.
