Brazil advances in regulatory transition for clinical research
Publication of Technical Note No. 43/2025 – Department of Science and Technology (“DECIT”) / Secretariat of Science, Technology, and Innovation in Health (“SECTICS”) / Ministry of Health (“MS”)
The Ministry of Health has published Technical Note No. 43/2025, providing guidance for the processing and risk classification of research involving human subjects within the National System of Ethics in Research with Human Subjects (“SINEP”). This marks an important step in the regulatory transition from the previous system — Research Ethics Committees (“CEPs”) and the National Research Ethics Commission (“CONEP”) — to the new framework established by Law No. 14,874/2024 and regulated by Decree No. 12,651/2025.
Key points
- New regulatory structure: Credentialed CEPs continue to review low and moderate-risk studies; Accredited CEPs have exclusive authority to review high-risk protocols.
- Definition of high risk: Currently based on CONEP standards (Resolution of the National Health Council – CNS No. 466/2012 and Circular Letter No. 172/2017), including research on human genetics, assisted reproduction, invasive devices, indigenous populations, biobanks, and foreign sponsorship. Important: this point will likely be subject to new regulation, bringing greater clarity and predictability.
- CONEP will act only as an appeals body until the National Authority for Ethics in Research (“INAEP”) is established, reinforcing qualified decentralization.
- Technological update: Plataforma Brasil will be adapted for automatic risk classification, ensuring greater agility and legal certainty.
Accredited CEPs
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)
- Hospital Israelita Albert Einstein (HIAE)
- A.C. Camargo Cancer Center
- Instituto Dante Pazzanese de Cardiologia (IDPC)
- Faculdade de Medicina do ABC (FMABC)
- Faculdade de Medicina de São José do Rio Preto (FAMERP)
- Faculdade de Medicina de Catanduva (FACERES)
- Faculdade de Medicina de Botucatu (FMB)
Why this matters
Brazil is experiencing a positive and strategic moment for clinical research, with a regulatory model that seeks greater efficiency, transparency, and ethical governance, aligned with international best practices. However, given the transitional nature of the systems, it is strategically important not to accept the status quo: the provisions of the law that do not depend on further regulation must be complied with immediately. In this context, both a thorough regulatory analysis of the applicable norms and documents submitted to CEPs, and of the contracts governing the relationships among sponsors, Contract Research Organizations (CROs), research centers, institutions, and principal investigators, becomes essential to ensure legal certainty and compliance.
Our Life Sciences & Healthcare team is closely monitoring these developments and remains available to assist national and international companies in adapting their protocols and regulatory strategies.