Brasília – Anvisa suspended the ongoing revision of RDC 327/2019, the regulation that governs the authorization, manufacture, importation and commercialization of cannabis-based products for medicinal use in Brazil. According to the agency, the interruption was requested by the technical areas involved, which argued that the proposed updates require additional analysis and broader alignment before moving forward to public consultation. The regulatory impact assessment already carried out will be preserved and may be revisited when the process resumes.

The suspension delays anticipated adjustments to Brazil’s medical cannabis framework, which stakeholders expected to address market expansion, product classification, quality requirements and pathways for national production. Industry representatives expressed concern about the uncertainty created by the pause, while patient groups noted that regulatory clarity remains essential to improving access and affordability of cannabis-based therapies.

Source: Panorama Farmacêutico