Public Consultation on clinical trial regulations in Brazil

Recently, on April 30th, 2024, the Brazilian Health Regulatory Agency, Anvisa, took a significant step forward during its 7th Public Ordinary Meeting of the Collegiate Board. It approved the commencement of a Public Consultation (CP) for the revision of Collegiate Board Resolution (RDC) No 9/2015, which pertains to the conduct of clinical trials aimed at registering medicines in Brazil. 

At the heart of this regulatory endeavor is a fundamental commitment to enhancing Anvisa’s oversight in approving and monitoring clinical trials, with a focus on mitigating health risks. As Ms. Meiruze Freitas, the rapporteur, articulates, the guiding principle behind revising RDC No. 9/2015 is to align Anvisa’s regulatory role with advancements in scientific and technological knowledge. This alignment is key for creating a regulatory environment supportive of clinical research in Brazil, adhering to international best practices. 

Furthermore, the landscape of medical innovation is rapidly evolving, characterized by the emergence of groundbreaking therapies and significant advancements in scientific understanding. Consequently, regulatory frameworks must evolve in tandem to accommodate these developments and maintain alignment with global standards. This absolutely highlights the necessity for a regulatory framework that promotes innovation while ensuring the highest standards of safety and efficacy.  

Central to the RDC No. 9/2015 revision process is the Regulatory Impact Analysis (AIR) report, which justifies the necessity of revising existing regulation to adapt to evolving innovation landscapes and harmonize Brazilian regulatory framework with international standards.  

In essence, the revision efforts outlined in the AIR linked to RDC No. 9/2015 entail streamlining its timelines, implementing risk-based approaches to work methodologies, and enhancing the clarity and efficacy of existing regulatory text. 

A critical aspect of the revision process is the establishment of criteria supporting the continued application of reliance mechanisms and the expansion of the scope to focus technical efforts on evaluating clinical developments posing higher risks to trial participants. Emphasis is placed on optimizing the analysis of the experimental drug dossier and the specific clinical trial dossier, with a risk-based approach guiding the assessment process.  

Additionally, the revision process addresses the unique challenges posed by first-in-human (FIH) clinical trials, necessitating additional documentation such as toxicity reports and pharmacokinetic/pharmacodynamic models to ensure participant safety. Similarly, post-marketing surveillance studies assume critical importance in monitoring drug safety and efficacy post-approval, necessitating clear regulatory guidelines to facilitate their execution. 

In parallel with regulatory revisions, legislative advancements are also underway to fortify the framework governing clinical research in Brazil. The recent approval of the Clinical Research Legal Framework by the National Congress features a commitment to delineating clear rules for human research and ensuring adherence to Good Clinical Practices. 

As we navigate this dynamic regulatory landscape, it is necessary to move away from a one-size-fits-all regulatory approach and embrace flexibility, proportionality, and risk-based analysis. Regulatory innovation must be the cornerstone of our approach, supporting continuous improvement and the conduct of clinical trials while safeguarding participant welfare. 

The forthcoming 45-day Public Consultation period presents a unique opportunity for stakeholders, including industry entities and the general populace, to contribute their insights and suggestions. This way we can collectively shape a regulatory framework that fosters innovation and also upholds the highest standards of patient safety and scientific integrity. 

These (combined) ongoing efforts to revise clinical trial regulations in Brazil signify a decisive moment in the nation’s life sciences and healthcare landscape. By aligning regulatory frameworks with international best practices, embracing innovation, and prioritizing patient safety, Brazil is poised to emerge as a beacon of excellence in clinical research on the global stage. 

 

Info Authors 

• Bruna B. Rocha, Partner, Life Sciences, Healthcare, Cannabis <bruna.rocha@cmalaw.com>  
• Juliana Marcondes de Souza, Associate, Life Sciences, Healthcare, Cannabis <juliana.marcondes@cmalaw.com> 
• Victoria Cristofaro Martins Leite, Associate, Life Sciences, Healthcare, Cannabis <victoria.cristofaro@cmalaw.com>