Anvisa Launches Public Consultations to Revise Herbal Medicines Regulatory Framework

The Brazilian Health Regulatory Agency (Anvisa) has announced the launch of three public consultations (CPs) to revise the regulatory framework for herbal medicines. This initiative, announced on November 27, 2024, also includes the approval of the Regulatory Impact Analysis Report (AIR) for this revision process. This initiative aims to ensure safe and rational access to medicinal plants and herbal medicines for the Brazilian population while promoting the sustainable use of biodiversity and strengthening the local pharmaceutical industry.

Overview of Proposed Changes

The public consultations address updates to Resolution RDC 26/2014 and its complementary normative instructions (INs). The focus areas are:

1. Simplified Registration Process: The first consultation deals with the registration of herbal medicines.

2. Restrictions and Prohibitions: The second consultation deals with rules on restrictions and prohibitions related to the registration and notification of herbal medicines.

3. Pesticide Residue Lists: The third consultation deals with a review of the list of pesticide residues evaluated in cultivated plant species used in herbal medicine production.

The consultations also include a proposal for a new guideline for the registration and notification of herbal medicines, which will replace the existing IN 04/2014.

Importance of Herbal Medicines in Brazil

Herbal medicines, derived from medicinal plants, are recognized by the World Health Organization (WHO) as an important therapeutic option. In Brazil, they are widely used and are an integral part of the National Policy on Medicinal Plants and Herbal Medicines (PNPMF). This policy seeks to:

• Ensure safe access to herbal medicines.

• Promote the sustainable use of biodiversity.

• Develop the national production chain and pharmaceutical industry.

The revisions aim to align Brazil’s herbal medicine regulations with international standards, improve domestic access to quality products and enhance their global competitiveness.

Public Participation and Contributions

To ensure transparency and inclusiveness, Anvisa is inviting contributions from the public, academia and industry stakeholders, the deadline is the 5th of March 2025. The results are expected to bring Brazil’s regulatory framework closer to international benchmarks and promote a safer, more efficient and competitive herbal medicine market. For more details, refer to the consultation here (in Portuguese).