Joint EDQM-EPAA Symposium: Pyrogen testing 2.0: Ethical, Evolving and Eco-friendly - Implementing safe, rapid, state-of-the-art and sustainable non-animal approaches worldwide, 25-26 February 2026
In February 2023, the EDQM and European Partnership for Alternative Approaches to Animal Testing (EPAA) hosted a landmark conference to present the European Pharmacopoeia (Ph. Eur.) Commission’s strategy to phase out the rabbit pyrogen test (RPT) and transition to modern, animal-free alternatives. This shift was guided by ethical imperatives in line with the principles of Directive 2010/63/EU on the protection of animals used for scientific purposes, and grounded in state-of-the-art scientific innovation, with a strong focus on enhancing patient safety.
All references to the RPT were then deleted from Ph. Eur. texts, with an implementation date of 1 July 2025, and the dedicated RPT chapter was officially suppressed on 1 January 2026. Rather than prescribing a single replacement test, the Ph. Eur. introduced a new general chapter, 5.1.13. Pyrogenicity, which places the onus on users to select the most appropriate pyrogenicity testing strategy based on scientific justification and a risk assessment.
Among the available alternatives, the monocyte activation test (MAT) is rapidly gaining ground as a scientifically robust, animal-free method.
This follow up symposium:
- provided updates on the implementation of the RPT phase out strategy across Europe and beyond;
- examined the challenges encountered during the transition to MAT and the solutions found;
- reviewed the status of recombinant reagents for the bacterial endotoxins test (BET);
- shared how other pharmacopoeias and regulatory frameworks outside Europe were adapting to the Ph. Eur.’s initiative;
- presented perspectives from regulators, industry and international stakeholders on the future of animal free pyrogenicity testing.
The symposium also offered participants the opportunity to familiarise themselves with the status of recombinant reagents, such as recombinant factor C (rFC) and recombinant cascade reagents (rCR), used in the BET.
The topic and content of this symposium will be of interest to professionals from the pharmaceutical and biopharmaceutical industries, contract laboratories and health authorities.
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