Brazil to inspect products from traditional Chinese medicine

The Brazilian Health Surveillance Agency (“Anvisa”) will monitor for the next three years the manufacture and trade of products from traditional Chinese medicine in Brazil. The resolution came into force Monday (Apr. 28).

According to the institution, the products from traditional Chinese medicine are those whose composition derive from raw material of vegetal or mineral origin, fungi or other ingredients from Chinese pharmacology.

Anvisa further announced the exclusively industrial manufacture of the products, and that only qualified workforce is allowed in the production, so as to ensure the quality and reliability of products.

The norm also stipulates that these products should display on their labels the name of the manufacturer along with the professional in charge, and must not define, either on the label or as part of other informative material, the product’s therapeutic uses.

The regulation further requires Anvisa to devise a system for quality inspection on their website, where professionals should, and customers are advised to, report any adverse reactions to the products.

During the monitoring period, professionals licensed to write out prescriptions are required to report any adverse reactions to the products. Additionally, Brazil-based companies will also have to register with Anvisa all active pharmaceutical supplies used.

Translated by Fabrício Ferreira