ANVISA - Alternative pyrogen test in the Brazilian pharmacopoeia

As a country with a large population, Brazil plays a not insignificant role for many pharmaceutical manufacturers and many international companies have production facilities in Brazil. The Brazilian authorities also regularly inspect international manufacturers that supply to Brazil. In November, Anvisa approved the 7th edition of the Brazilian Pharmacopoeia, which updates the compendium with the addition of 12 new articles, including methods, monographs and pharmacopoeial texts.

What is the Brazilian Pharmacopoeia?

The Brazilian Pharmacopoeia, called Farmacopéia Brasileira in Portuguese, is an official document that establishes the quality standards for medicines and pharmaceutical products in Brazil. It serves as a reference for the manufacture, testing and control of medicines and ensures that these products are safe, effective and of high quality.

The pharmacopoeia defines in detail the requirements for active ingredients, excipients, pharmaceutical preparations and the associated test methods. It also contains specific monographs that provide precise descriptions of the physical, chemical and microbiological properties of medicinal products and their components. These monographs serve as guidelines for quality control in the pharmaceutical industry and guarantee standardised quality on the market.

In addition, the pharmacopoeia is an essential instrument for regulation and monitoring by state authorities such as ANVISA (Agência Nacional de Vigilância Sanitária), which is responsible for health safety in Brazil. The aim of the pharmacopoeia is to protect public health by ensuring that medicines comply with established standards and do not pose any risks to consumers.

The work of the Pharmacopoeia is carried out by thematic committees made up of highly specialised experts who pass on their knowledge and perform this important task on a voluntary basis.

For the 7th edition of the compendium, two working groups were also formed to draw up the proposals for the chapter on the monocyte activation test and the chapter on in vitro-in vivo correlation studies.

Monocyte activation test

One of the innovations in the new edition is the inclusion of the monocyte activation test (MAT). Following other pharmacopoeias, Brazil is now also following the direction of establishing an alternative approach to the rabbit test. The MAT is an alternative method for the evaluation of pyrogens, i.e. substances that increase body temperature, compared to the use of animals.

This also makes it possible for manufacturers who sell or produce their products in Brazil to use the MAT, as the pharmacopoeia represents the validity of the test for the purposes of legalisation and inspection.

With the MAT test, Brazil is following the direction of prioritising strategies to reduce the use of animal testing. However, the pyrogen test on rabbits will be retained in the new version due to technical limitations.

Summarising the current version, Anvisa states:

‘The update of the pharmacopoeia is the result of several public consultations that took place in 2023 and 2024. In total, the text was updated with the inclusion of 12 methods, monographs and pharmacopoeial texts, the revision of another 47 points and the exclusion of two texts.

The 7th edition of the Brazilian Pharmacopoeia is in fact an update of the 6th edition and is called a new edition to highlight the process of consolidation of the previous updates and to mark an important milestone: the celebration of the 25th anniversary of Anvisa.’

Further information can be found directly on the Homepage of ANVISA.