Anvisa approves new framework for herbal medicines in Brazil

Anvisa has approved the new regulatory framework for the registration and notification of herbal medicines, streamlining and opening pathways for the sustainable development of new products from Brazilian biodiversity.

One of the central points in the norm update is the plant extracts that give rise to the herbal medicine. The norm brings innovation by changing the way industries produce and control these extracts used in the manufacture of herbal medicines. The new rule simplifies and considers the different levels of knowledge regarding plants with therapeutic activity.

This change should bring new scenarios for the herbal medicine industry in Brazil, as the previous rule was based on the logic of synthetic drugs, whose production and quality control are different from medicines made from plants.

The new approach takes into account that, for some plants, science knows exactly which substance has therapeutic activity; in other cases, the plant is proven effective, but it is not possible to pinpoint the specific substance responsible for the therapeutic activity. Thus, the approved regulation will bring different technical requirements to prove the quality of the plant active ingredient used in the herbal medicine, depending on each case.

The new framework increases the potential use of Brazilian biodiversity. Despite having the world's largest biodiversity, Brazil still has a small number of herbal medicines. Currently, there are about 350 of them regulated by Anvisa, while the United Kingdom has 3,000 and Germany 10,000 products. It is estimated that only 15% of plant species in Brazil have been studied for medicinal purposes.

What was approved

The update of the herbal medicine regulatory framework involves the new Collegiate Board Resolution (RDC) dealing with the registration and notification of herbal medicines, and three Normative Instructions (INs) dealing with simplified registration, evaluation of pesticide residues in herbal medicines, and restrictions on the composition of these medicines.

The new regulation was approved at the Collegiate Board meeting this Wednesday (12/17) and will be published in the Official Gazette in the coming days.

International Market

The new regulatory framework brings Brazilian rules closer to those established internationally, especially those of the European Medicines Agency (EMA). In practice, this represents the possibility of opening new markets for national manufacturers.

With this initiative, Anvisa updates rules that had not been fully reviewed for over 10 years. For this update, public consultations and hearings were held, as well as a series of events and meetings with researchers and the industry involved.

Source: Anvisa (Reproduction of content originally published on the website of the National Health Surveillance Agency - Anvisa on December 17, 2025)