European Pharmacopoeia removes rabbit pyrogen test from its repertoire

Published: 18-Jul-2024
Regulatory

The development will require medicine developers to use in vitro testing instead of RPT to determine the pyrogen levels in its injectables

The European Pharmacopoeia Commission (EPC) has decided to eliminate the Rabbit Pyrogen Test (RPT) from its monographs.

Pyrogens are fever-inducing contaminants that can be present in injectable medicines — most often unintentionally. Because pyrogens can have a significant impact on the health of a person exposed to them, their detection is essential to ensure that injectable medicines are safe.

For many years, the RPT has been the standard approach to detrmining the levels of pyrogens in pharmaceuticals, and this tends to claim around 400,000 rabbits per year worldwide.

Following a broad exercise aiming at the complete removal of the RPT from the European Pharmacopoeia (Ph. Eur.), in June 2024 the EPC adopted 57 revised texts from which the RPT has been deleted, together with a new general chapter on Pyrogenicity (5.1.13), marking the end of the RPT era in the Ph. Eur.

Now, no text from the organisation will require the use of RPT. It will now be up to the medicine developer to select a suitable in vitro test, which will be based on a risk assessment as described in the new general chapter.

The revised texts omitting the RPT and the new chapter, Pyrogenicity (5.1.13), will be published in Supplement 11.8 of the Ph. Eur., with an implementation date of 1 July 2025

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  • European Pharmacopoeia Commission
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