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2 min read
In 2024, the National Health Surveillance Agency (ANVISA) marked a historic milestone: 25 years since the enactment of Law No. 9,787/1999, which created the category of generic medicines in Brazil and redefined access to safe, effective, and affordable treatments.
Since then, Brazil has evolved from a market dependent on imported innovative products to a regional benchmark in pharmaceutical regulation, equitable access, and healthcare system strengthening across Latin America.
Evolution and Regulatory Milestones
Law No. 9,787/1999 (which amended Law No. 6,360/1976) established the legal foundation for generic medicines in Brazil, introducing essential concepts such as bioequivalence, relative bioavailability, and interchangeability.
Following its enactment, ANVISA implemented complementary technical regulations, including RDC No. 134/2003, and recently RDC No 753/2022. which set clear requirements for registration, quality control, and labeling to ensure consistency, safety, and transparency.
Over the past two decades, ANVISA has refined its pharmaceutical equivalence and bioequivalence assessment procedures, issued updated guidelines on bioavailability and bioequivalence studies, and strengthened post-marketing surveillance to enhance traceability and patient safety.
The result is a solid and internationally recognized regulatory framework that has built long-term confidence among healthcare professionals and patients alike.
Impact on Access and Market Competitiveness
Brazil’s generic medicines policy remains one of the most impactful in Latin America, significantly improving access to essential drugs and reducing treatment costs in both public and private healthcare systems.
The Farmácia Popular Program, led by the Ministry of Health, played a crucial role by expanding the nationwide distribution of subsidized generic drugs, bringing affordable therapies to millions of Brazilians.
From a market perspective, the framework stimulated the entry of new manufacturers, expanded therapeutic portfolios, and fostered a more mature and transparent pharmaceutical environment.
Today, generics account for over 35% of total drug sales in Brazil, a testament to the program’s success and its role in driving incremental innovation and continuous quality improvement.
Regulatory Challenges and the Road Ahead
While Brazil’s model for generic medicines has become a regional reference, it now faces new challenges.
Key priorities include updating bioequivalence and pharmacovigilance guidelines in line with international standards (ICH, EMA, WHO), maintaining product quality amid pricing pressures, and enhancing traceability and digital oversight throughout the product lifecycle.
ANVISA continues to invest in digital transformation of its drug approval processes, seeking greater agility, predictability, and transparency.
The next step involves integrating regulatory intelligence tools and data-driven systems to strengthen post-marketing monitoring and support a more efficient, sustainable market access ecosystem.
After 25 years, Brazil’s experience demonstrates how evidence-based and equitable regulation can become a driver of innovation, competitiveness, and credibility across Latin America.
Strategic Opportunities and the Role of Innovation
Brazil’s evolving regulatory landscape offers significant opportunities for companies that act ahead of change.
As ANVISA moves toward a more digital and transparent model, organizations with strong compliance strategies can transform regulation into a competitive advantage.
Collaborating with experts who combine local insight and global regulatory expertise helps streamline submissions, accelerate approvals, and align with international best practices in bioequivalence, pharmacovigilance, and reliance.
Leveraging end-to-end regulatory solutions, digital platforms, and AI-driven tools enables predictive decision-making and strengthens lifecycle management across markets.
This balance of strategy, technical rigor, and innovation reflects how Freyr LATAM empowers pharmaceutical companies to achieve smarter, faster, and more sustainable regulatory success in Brazil and the region.
Looking to strengthen your regulatory strategy or expand your portfolio in Brazil? Contact us
