ANVISA Opens Public Consultation to Update Rules for Medical Cannabis Products

In July 2025, ANVISA opened a new Public Consultation to update RDC No. 327/2019, which currently regulates cannabis products for medical use in Brazil. The initiative aims to review technical and operational criteria to keep up with scientific evolution, ensure greater regulatory certainty, and expand access to cannabis-based therapies.

QR Group, a consulting firm specializing in health product regulation, analyzes the agency’s proposals and guides companies in the sector on the impacts, risks, and opportunities in the new regulatory scenario.

What does ANVISA’s update proposal provide?

The Public Consultation brings a series of important changes to the medical cannabis market. Key points under discussion include:

• Possibility of definitive sanitary registration for cannabis products, replacing the current model of temporary authorization;

• Reinforcement of quality, safety and clinical efficacy criteria;

• Inclusion of specific requirements for pharmacovigilance and monitoring of adverse events;

• Update of the requirements for import and national manufacturing, including new parameters for raw material control.

With the proposal, ANVISA intends to migrate from a provisional model to a more robust, structured and permanent system, approaching international standards such as those adopted by EMA, Health Canada and FDA.

Impacts for companies that operate or wish to work with medical cannabis

The proposed changes require extra attention from companies that already have approved products or intend to enter the sector. Among the main impacts are:

• Need to review and expand technical dossiers to meet the criteria for definitive registration;

• Adoption of stricter quality processes, especially in relation to the traceability of the production chain;

• Strengthening the regulatory and pharmacovigilance infrastructure;

• Restructuring of regulatory and market entry strategies.

Companies that anticipate the new standard will have a better chance of maintaining or gaining space in the growing market.

How QR Group can support your company in this new regulatory landscape

QR Group offers complete technical support for companies that operate or wish to work with cannabis products for medicinal use in Brazil. Our services include:

• Regulatory impact analysis based on ANVISA’s new proposal;

• Adequacy of technical dossiers and clinical studies to the new requirements;

• Support in the development of definitive registration strategies;

• Quality, traceability and pharmacovigilance consulting for full compliance.

Our goal is to ensure that our clients are prepared to grow safely, within the new requirements of Brazilian regulation.

Talk to QR Group

Does your company work with medical cannabis and need to adapt to ANVISA’s new requirements?
Count on QR Group to ensure registration, compliance, and sustainable growth in Brazil.

Source: ANVISA