ANVISA approves Regulatory Impact Analysis Report on Cannabis Products for Medical Purposes

by , | May 20, 2024 | Client Alert, Pharma, Regulatory

On May 15, 2024, the Board of Directors of the Brazilian Health Regulatory Agency (ANVISA) approved a Regulatory Impact Analysis Report addressing advances and challenges in regulating cannabis products for medical purposes in Brazil. The report aims to ensure the availability of high-quality, evidence-based medical cannabis products.

Key points include:

  • Proposal to review criteria and requirements under the current rule (RDC No. 327/2019).
  • Establishment of mechanisms for the safe and rational use of cannabis derivatives.
  • Promotion of scientific dissemination actions to inform the public and professionals involved about the rational use of medical cannabis and the associated risks.
  • Increase access to medical cannabis products in terms of cost, quality, and availability.
  • Facilitation of research activities on the Cannabis sativa species.
  • Contribution to the discussion on the potential medical uses of cannabis, aligned with international best practices.
Please note that in the period from March 2020 (implementation of RDC No. 327/2019) until October 2023, ANVISA received 131 applications for Sanitary Authorization, with 31 approved, 38 awaiting technical analysis and the remainder under review or have been closed/rejected. The authorized products consist of 19 CBD (phytopharmaceuticals) and 12 cannabis extracts (herbal medicines).
It is important to note that the report represents an analysis phase and exploration of alternatives, without proposing specific regulatory changes yet.

If you have any questions or would like to get more information, do not hesitate to get in touch with our team. We will be glad to assist you.


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