ANVISA Regulatory Changes Brazil: Impact on Oncology & Infectious Disease Trials

Key Takeaways

• Regulatory modernization: Law 14.874/2024 established the Brazilian System of Ethics in Research involving Humans, decentralizing ethics reviews from CONEP to local Research Ethics Committees (CEPs) at institutions.
• Defined timelines: RDC 945/2024 mandates 90-day response timelines for low-risk trials and 120 days for high-risk trials, replacing indefinite review periods.
• Post-trial access clarity: Investigational treatments may continue after trial completion under defined conditions, addressing ethical concerns about treatment discontinuation in oncology and infectious disease.
• Parallel processing: Local ethics committees now conduct reviews concurrently with ANVISA technical assessment rather than sequentially, reducing approval bottlenecks.
• ICH alignment: Both laws incorporate Good Clinical Practices (GCPs) aligned with ICH E6 standards, harmonizing Brazil with international regulatory frameworks.

Overview of ANVISA's Regulatory Modernization

Brazil's clinical trial regulatory environment underwent substantial reform in 2024. Two landmark measures now govern research involving humans: Law 14.874/2024 (enacted May 28, 2024) and RDC 945/2024 (issued November 29, 2024). These represent ANVISA's most comprehensive modernization effort in recent years. These changes align with ANVISA's broader regulatory modernization strategy for the pharmaceutical sector.

Prior to these reforms, Brazil's clinical trial approval process faced centralized ethics review bottlenecks through CONEP (National Research Ethics Commission). Approval timelines frequently extended beyond 12 months. Post-trial patient access rules remained ambiguous. These factors discouraged multinational pharmaceutical sponsors from prioritizing Brazil as a trial destination.

The reforms reflect ANVISA's strategic objective to harmonize Brazil's clinical trial framework with international best practices. This modernization is significant given Brazil's role as Latin America's largest pharmaceutical market. The country offers substantial patient populations in oncology and infectious disease, making regulatory efficiency gains consequential for global drug development.

What Changes Did Law 14.874/2024 Introduce?

Decentralization of Ethics Committee Reviews. A cornerstone of the reforms is the shift from centralized CONEP review to local Research Ethics Committees (Comitês de Ética em Pesquisa, or CEPs). Law 14.874/2024 establishes two tiers of committees: licensed CEPs for low and moderate-risk research, and accredited CEPs for high-risk research. This structural change enables local committees to conduct initial ethics reviews in parallel with ANVISA's technical assessment.

Institutional Expertise. Local committees operate within academic medical centers and research institutions across Brazil. They evaluate protocol design, informed consent procedures, and investigator qualifications. This distributed approach accelerates approval timelines by leveraging institutional expertise in research ethics.

Regulatory Definitions. The law defines key terms including Good Clinical Practices (GCPs), audit procedures, and research participant protections. Article 2 defines Good Clinical Practices as standards "in accordance with international standards and best practices" for planning, conducting, monitoring, and reporting research.

How Does RDC 945/2024 Define ANVISA Response Timelines?

Risk-Based Timeline Categories. RDC 945/2024 establishes explicit ANVISA response windows based on trial risk categories. Article 6 defines three categories: low risk, moderate risk, and high risk. Low-risk trials receive 90-day response timelines. High-risk trials receive up to 120 days. These defined timelines apply to clinical trials with medicinal products seeking marketing authorization in Brazil.

Scope of Application. The resolution applies to clinical trials with synthetic, semi-synthetic, herbal, biological, and biosimilar medicinal products. It covers trials for new therapeutic indications, new administration routes, new concentrations, and post-marketing authorization changes requiring clinical data. Post-marketing (phase IV) trials and non-interventional research fall outside this regulation.

Contractual Certainty. The formalized timeline creates certainty for sponsors and contract research organizations (CROs). Project scheduling and resource allocation now operate with transparent regulatory expectations. This contrasts sharply with previous processes that lacked published timelines and were subject to indefinite extension.

What Do the Post-Trial Access Rules Specify?

Continuity of Care Provisions. RDC 945/2024 explicitly clarifies post-trial access provisions. Investigational treatments may continue to be provided to trial participants after protocol completion under defined conditions. This addresses a significant source of regulatory uncertainty that previously complicated trial enrollment discussions.

Ethical Protection. The clarification reduces ethical concerns regarding abrupt treatment discontinuation upon trial conclusion. This protection is particularly important in oncology and infectious disease populations. Treatment interruption in these therapeutic areas may have serious clinical consequences. Enhanced clarity improves patient recruitment and informed consent procedures.

Impact on Oncology and Infectious Disease Trials

The regulatory reforms have catalyzed expansion in Brazil's oncology and infectious disease sectors. Streamlined approval processes and regulatory certainty removed barriers to trial initiation. Sponsors now launch studies with reduced administrative delay.

Oncology Trial Growth. Oncology trials represent a substantial proportion of Brazil's clinical research portfolio. The country faces growing cancer incidence and maintains established oncology research infrastructure. The ANTARES study (NCT06638931) exemplifies this growth—a phase II basket trial evaluating anti-PD1 therapy for rare tumors led by Instituto do Cancer do Estado de São Paulo. See also recent oncology approvals demonstrating Brazil's expanding clinical trial capacity.

Infectious Disease Research. Brazil's geographic and epidemiological diversity positions the country for infectious disease trials. Research capacity exists for endemic conditions including dengue and tuberculosis. The reforms enhance this strategic advantage by reducing approval friction for infectious disease indications.

Patient Recruitment Benefits. Clearer timelines reduce trial startup delays. Sites initiate enrollment with greater certainty regarding regulatory milestones. Post-trial access clarification removes a significant source of patient hesitation. Individuals and their clinicians can now anticipate continued access to investigational treatments after protocol completion.

Why Are Foreign Sponsors Investing in Brazil?

Regulatory Certainty. Multinational pharmaceutical sponsors evaluate trial destinations based on regulatory predictability and approval timelines. Brazil's reforms directly address these criteria. The defined ANVISA timelines and clarified procedures provide transparency. The decentralized ethics review system operates with maintained scientific rigor.

Strategic Market Position. Brazil offers access to diverse patient populations with limited prior exposure to investigational agents. Established academic medical centers provide research capacity and regulatory experience. Geographic diversity spans multiple climate zones relevant to infectious disease epidemiology. Companies looking to enter the market should review expedited approval pathways for foreign-sponsored trials.

Competitive Advantages. Foreign sponsors can now incorporate Brazil into global trial strategies with confidence. The regulatory efficiency advantage is pronounced for oncology and infectious disease programs. These therapeutic areas benefit from Brazil's large patient populations and established research infrastructure.

Future Outlook: Sustaining Regulatory Growth

Digital Innovation Potential. ANVISA may implement digital tools for trial protocol submission and tracking. Real-time visibility into review status would reduce administrative burden. Integration of academic clinical research centers into a coordinated national network could enhance site capacity and standardize training.

Priority Pathways. ANVISA may expand priority review pathways for trials addressing unmet needs in rare diseases or emerging infections. This would further accelerate approval timelines for strategically important indications. Digital innovation in informed consent procedures may emerge as an area of regulatory focus.

Predicted Trends. Brazil's trial environment will likely see continued expansion of investigator-initiated trials. Increased adoption of adaptive trial designs and basket trials across oncology programs appears likely. Growing investment in infectious disease trials addressing antimicrobial resistance and endemic infections will continue.

Frequently Asked Questions

Primary Sources

1. Brazilian Health Regulatory Agency (ANVISA). Law No. 14,874 of May 28, 2024 — Establishes the Brazilian System of Ethics in Research involving Humans. Official Gazette of the Federative Republic of Brazil.
2. Brazilian Health Regulatory Agency (ANVISA). Collegiate Board Resolution – RDC No. 945 of November 29, 2024 — Provides guidelines and procedures to conduct clinical trials in Brazil.
3. Presidency of the Republic of Brazil. Decree No. 12,651 of October 7, 2025 — Regulates Law No. 14,874/2024.
4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH E6(R2) Good Clinical Practice Guidelines — Integrated into Brazilian regulations via Law 14.874/2024.
5. U.S. National Library of Medicine. ClinicalTrials.gov Identifier: NCT06638931 — ANTARES Phase II Basket Study, Instituto do Cancer do Estado de São Paulo.