The European Pharmacopoeia (Ph. Eur.) has published the 59 texts (1 new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) concerned by the rabbit pyrogen test (RPT) replacement strategy for public consultation in Pharmeuropa 35.1, with a commenting deadline of 31 March 2023.
These texts, covering a variety of topics including vaccines for human use, blood products, antibiotics, radiopharmaceuticals and containers, have been revised to replace the RPT with an in vitro alternative, the monocyte activation test (MAT) or another animal welfare-compatible approach. Their publication marks a significant step in the strategy decided by the Ph. Eur. Commission in June 2021 that should ultimately lead to the complete replacement of the rabbit pyrogen test (RPT) in the Ph. Eur., envisaged within the next three years. This aim and how it will be achieved is more fully discussed in the pyrogenicity strategy paper published in September 2022.
The Ph. Eur. would like to encourage all stakeholders to provide their comments on the published texts before 31 March 2023 via the appropriate channel. More information on how to comment can be found here: “Comment on drafts (Pharmeuropa)”.