Brazil Updates Herbal Medicines Regulatory Framework

Brazil has strengthened oversight of herbal medicines through new legal and technical measures, including updated compliance requirements and administrative governance.

Compliance Overview: Brazil’s Updated Regulatory Framework for Herbal Medicines

Brazil has recently strengthened its oversight of herbal medicines through two key Normative Instructions (NI) issued by the National Health Surveillance Agency (ANVISA) on 17 December 2025. These measures introduce updated compliance requirements, administrative governance structures, and technical specifications for the registration, composition, and market authorization of herbal products. Below is a structured analysis of the new regulations based on the provided sources.

Regulation Analysis

The following table summarizes the key regulations, their requirements, and associated details:

Detailed Requirements

1. Normative Instruction (NI) 411 – Composition of Herbal Medicines

This regulation imposes restrictions and prohibitions on the ingredients and formulations of herbal medicines to ensure safety and efficacy. While the full text is available only in Portuguese¹, the key provisions include:

• Prohibited substances: Certain herbs, extracts, or chemical constituents may be banned due to toxicity, lack of scientific evidence, or public health risks¹.
• Restricted use: Some ingredients may be permitted only under specific conditions (e.g., dosage limits, labeling requirements, or professional supervision)¹.
• Technical justification: Manufacturers may need to provide scientific data or traditional use evidence to support the inclusion of certain ingredients¹.

Enforcement Authority: ANVISA is responsible for enforcing these compositional rules, including market surveillance and product recalls if violations are detected¹.

2. Normative Instruction (NI) 412 – Simplified Registration Lists

This regulation introduces two simplified registration pathways to expedite market access for qualifying herbal products:

• List of Simplified Market Registration Herbal Medicines: Products meeting predefined criteria (e.g., well-documented safety/efficacy, low-risk profiles) may qualify for faster registration².
• List of Simplified Market Registration Traditional Herbal Products: Products with a long history of traditional use (e.g., those recognized in pharmacopeias or traditional medicine systems) may benefit from streamlined approval².

Key Features:

• Reduced documentation: Applicants may submit abbreviated dossiers for products on the lists².
• Expedited review: ANVISA aims to shorten the evaluation timeline for qualifying products².
• Ongoing compliance: Products must adhere to post-market surveillance requirements, including adverse event reporting².

Enforcement Authority: ANVISA oversees the inclusion of products on these lists and monitors compliance with registration conditions².

Administrative Governance

The new regulations reflect Brazil’s efforts to harmonize herbal medicine oversight with international standards while addressing domestic public health priorities. Key governance aspects include:

• Centralized authority: ANVISA retains sole regulatory authority over herbal medicines, including registration, labeling, and post-market surveillance^{1, 2}.
• Transparency: The final texts of NI 411 and NI 412 are publicly available (in Portuguese) via ANVISA’s legislative portal^{1, 2}.
• Stakeholder engagement: The draft resolutions (1292 and 1293) were previously notified to the WTO Committee on Technical Barriers to Trade (TBT), allowing for international comments before adoption^{1, 2}.

Compliance Obligations for Industry

Manufacturers, importers, and distributors of herbal medicines in Brazil must:

1. Review compositional restrictions: Ensure products comply with NI 411’s prohibitions and restrictions¹.
2. Assess eligibility for simplified registration: Determine if products qualify for inclusion on the lists under NI 412².
3. Update dossiers: Submit revised registration applications reflecting the new requirements^{1, 2}.
4. Monitor updates: Stay informed about ANVISA’s guidance or amendments to the lists or compositional rules^{1, 2}.

Summary Answer

Brazil’s updated regulatory framework for herbal medicines, enacted through Normative Instruction (NI) 411 and NI 412 (adopted 17 December 2025), introduces stricter compositional controls¹ and simplified registration pathways for qualifying products². NI 411 restricts or prohibits certain ingredients in herbal medicines¹, while NI 412 establishes two lists to expedite market authorization for low-risk and traditional herbal products². These measures are enforced by ANVISA and align with Brazil’s broader efforts to enhance oversight while facilitating market access for compliant products^{1, 2}. Industry stakeholders must review their product portfolios for compliance with the new rules and leverage the simplified registration options where applicable.

Sources

1. ↩ Committee on Technical Barriers to Trade – Notification – Brazil – Herbal medicines – Addendum — SS / directdoc https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN24/BRA1575A1.pdf&Open=True
2. ↩ Committee on Technical Barriers to Trade – Notification – Brazil – Herbal medicines – Addendum — SS / directdoc https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN24/BRA1580A1.pdf&Open=True