Regulation of Cannabis Products for Medicinal Purposes Enters Anvisa's Regulatory Agenda 2024-2025
Review of the Brazilian Pharmacopoeia collegiates is also included in the Agenda
The Collegiate Board of the National Health Surveillance Agency (Anvisa) approved, on Wednesday (11/27), during the 23rd Public Ordinary Meeting of the Agency, the update of the Regulatory Agenda 2024-2025. From the consolidated updates, the new list of regulatory topics for the period 2024-2025 will consist of 171 topics, distributed across 16 macro themes of the Agency's activities.
Among the topics is the review of the regulation of cannabis products for medicinal purposes (Review of RDC No. 327/2019). According to the document, the objective is to "Enable safe access to essential products and services for the health of the population."
The Agenda also includes the review of the Brazilian Pharmacopoeia collegiates, an official code that recently had the addition of Cannabis sativa among its cultivars.
As provided in the Anvisa Regulatory Agenda Manual, the set of prioritized topics can be reviewed annually, with the possibility of changes, exclusions, and inclusions of topics. The aim of the annual update is to keep the document aligned with the regulatory priorities of the period, ensuring the predictability and relevance of the Agency's regulatory planning.
Once approved at the Anvisa Collegiate Board meeting, the Ordinance with the updated items of the Regulatory Agenda list for 2024-2025 will be published in the Official Gazette of the Union. The complete and updated list of topics is already available on the specific page of the Regulatory Agenda 2024-2025 on the portal.