Anvisa proposes new RDC for medicinal cannabis products and maintains RDC 660 out of the review

Anvisa's proposal establishes a new regulatory framework for industrialized medicinal cannabis products in Brazil

Published on 01/28/2026

Diretoria Colegiada da Anvisa tem nova composição definida após saída de diretor

Anvisa's draft updates rules for medicinal cannabis products and imposes stricter requirements on the market. Image | Reproduction

 

The National Health Surveillance Agency (Anvisa) has put up for public consultation a draft Resolution of the Collegiate Board of Directors (RDC) proposing the update of the regulatory framework for medicinal cannabis products in Brazil, revoking the current RDC 327/2019 and establishing new rules for the manufacture, import, and commercialization of industrialized cannabis-based products for human use.

Although the proposal brings relevant changes to the national market, one point caught attention: RDC 660/2022, which regulates the exceptional import of cannabis products by patients, was left out of the current review scope. The exclusion comes in a sensitive context, following recent attempts by Anvisa itself to revise the import rules. However, this does not rule out the possibility of the regulation undergoing an exclusive review throughout the year.

In December 2025, during preliminary discussions on updating RDC 327, Anvisa presented a proposal that could restrict imports via RDC 660, by conditioning authorization on the absence of products considered