
Client Alert
09/10/2025
Regulation of the Clinical Research Law and next steps
On October 8, 2025, Decree No. 12,651/2025 came into force, regulating Law No. 14,874/2024 and establishing the National System of Ethics in Research with Human Subjects (SNEP). The regulation consolidates guidelines for ethical approval, governance, and accreditation of Institutional Review Boards (IRBs, known as CEPs in Portuguese), bringing greater legal certainty to the sector. Topics …









