BRASÍLIA—The Brazilian Health Regulatory Agency has approved the 7th Edition of the Brazilian Pharmacopoeia and has included a human cell-based and animal-free method to test the safety of medicines such as vaccines. This decision will spare many animals from unnecessary testing procedures and mark a significant milestone in the medicinal testing landscape.
Since 2022, HSI in Brazil’s Research and Toxicology department has established a working group to support the implementation of the monocyte activation test, providing a discussion forum where technical and legislative challenges have been discussed and possible solutions explored. The working group held online workshops in 2022 and 2023.
Bianca Marigliani, senior principal strategist, Research and Toxicology, Humane Society International in Brazil, said: “We are delighted at the inclusion of the MAT in the Brazilian Pharmacopoeia. This reaffirms Brazil’s commitment towards eliminating and replacing obsolete animal tests for batch release testing of vaccines, blood-derived products and other medicines. We have been working on this with CONCEA, BraCVAM and local biopharmaceutical companies since 2022, and this collaboration has been pivotal. We look forward to facilitating such advancements in other areas of safety testing of biologicals and medicines too.”
The MAT is a human-specific test method that can detect all kinds of pyrogens—substances that can cause a rise in temperature—and is a significantly more accurate representation of human in vivo reactions to such substances. Its inclusion as an alternative method to the traditional rabbit pyrogenicity test, an outdated test from the 1950s, is a significant step for patient safety. The introduction is also an important step for animal welfare, since rabbits will no longer be required for the release of biological products, like vaccines and blood-derived products, as well as other injectables products.
The inclusion of the MAT as an alternative method to the RPT follows the official recognition of the method by CONCEA in 2019 and shows the commitment of ANVISA and others in Brazil on moving away from the use of animal testing in the regulatory environment.
By recognizing the advantages of a human-based test, like the MAT, Brazil aligns with the European countries, India, China and Japan which have included the MAT as an alternative method to RPT and contributes to the global regulatory alignment of tests for biopharmaceutical products, in particular vaccines.
Please access the official text here
ENDS
Media contact:
- Antoniana Ottoni, aottoni@hsi.org +55 61 98140 3636
