Four new Brazilian Pharmacopeia publications took effect on July 1, giving force to updated national standards that govern the quality of medicines and pharmaceutical inputs in Brazil.

The compendia were approved by the Brazilian Health Regulatory Agency (Anvisa) in May and launched at the 16th International Meeting of World Pharmacopeias, held June 15-18 in Brasília. The event marked the centenary of the Brazilian Pharmacopeia (1926-2026) and closed the five-year term of the Pharmacopeia’s collegiate bodies (2021-2026).

The four new publications are the Brazilian Pharmacopeia, 8th edition; the Homeopathic Pharmacopeia, 4th edition; the Brazilian Pharmacopeia Formulary, 3rd edition; and the Brazilian Pharmacopeia Herbal Medicines Formulary, 3rd edition.

The new edition of the main Brazilian Pharmacopeia adds 19 new texts, revises 122 texts, and incorporates 203 errata. The Homeopathic Pharmacopeia includes nine new monographs, adds macroscopic and microscopic images to eight existing monographs, includes 21 new texts, and revises 37 items. The Brazilian Pharmacopeia Formulary brings eight new texts and four revised texts. The Herbal Medicines Formulary consolidates updates made during the five-year work cycle, harmonizes definitions with the new regulatory framework, and implements a coding system for all monographs.

The Brazilian Pharmacopeia is the national pharmaceutical compendium that establishes, through pharmacopeial texts such as chapters, methods, and monographs, the minimum requirements for quality, authenticity, and purity of pharmaceutical inputs, medicines, and other products under health surveillance. It serves as the scientific reference for confirming the quality of drugs and raw materials and is also a source of regulatory information. For technical details on the new compendia, Anvisa recommends consulting the documents available on the Public Consultations pages under the Pharmacopoeia macro-topic.

Source: ANVISA Update