Regulating pharmaceutical products obtained from Cannabis sativa L. in Brazil and its challenges

Maíra Ribeiro de Souza
OrcID
Daniela Aparecida dos Reis Arquete
OrcID

    Maíra Ribeiro de Souza

    Agência Nacional de Vigilância Sanitária

    OrcID https://orcid.org/0000-0002-1003-2458

    Possui graduação em Farmácia com habilitação em Indústria pela Universidade Federal de Ouro Preto (2009), mestrado em Ciências Farmacêuticas pela Universidade Federal de Ouro Preto (2012) e doutorado em Ciências Farmacêuticas pela Universidade Federal do Rio Grande do Sul (2022). Atualmente, é Especialista em Regulação e Vigilância Sanitária na ANVISA. Possui experiência em química e farmacologia de produtos naturais e controle da qualidade de insumos ativos vegetais e fitoterápicos, com ênfase em desenvolvimento e validação de métodos analíticos.

    Daniela Aparecida dos Reis Arquete

    Agência Nacional de Vigilância Sanitária

    OrcID https://orcid.org/0009-0004-9353-8762

    Formada em Engenharia de Alimentos (Universidade Federal de Viçosa - UFV, 2001), com Mestrado em Ciência e Tecnologia de Alimentos (UFV, 2003), Especialização em Vigilância Sanitária (Fiocruz/DF, 2008) e Especialização em Tecnologia Farmacêutica e Cosmética (Faculdade Unyleya, 2022). Foi Professora Assistente na Coordenadoria de Educação Aberta e a Distância da UFV em 2004. Desde 2005 é servidora pública federal, como Especialista em Regulação na Agência Nacional de Vigilância Sanitária - Anvisa/ Ministério da Saúde.

Keywords

Medical Cannabis
Government Regulation
Health Policy
Evidence Gaps
Public Health

Abstract

Despite the growing interest in pharmaceutical products derived from Cannabis sativa L., most of the therapeutic claims related to the species lack robust scientific evidence, which hinders rational use. Other factors, such as the unequal access to available products, the asymmetry of information, and the social stigma surrounding the species, impose additional challenges for regulators. The Brazilian regulatory model has evolved over the last decade, most notably with the publication of RDC 327/2019, which enabled the Sanitary Authorization of cannabis products for medicinal purposes, expanding the alternatives available to patients unresponsive to other treatments. However, there are still challenges to overcome, as well as improvement opportunities, as pointed out by the Regulatory Impact Analysis (RIA) study conducted by the National Health Surveillance Agency (ANVISA), whose report was recently published. It is expected that the progress of the discussions on the subject, not only by Anvisa but also in other spheres, will contribute to the progress of the current model, based on available scientific knowledge, aiming to meet the population's needs.

References

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Regulating pharmaceutical products obtained from Cannabis sativa L. in Brazil and its challenges. Rev Fitos [Internet]. 2025 Sep. 1 [cited 2025 Dec. 8];19:e1808. Available from: https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/1808
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