Back European Pharmacopoeia Commission clarifies rFC integration and future innovation pathways

EDQM Strasbourg, France 26/01/2026
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European Pharmacopoeia Commission clarifies rFC integration and future innovation pathways

The European Pharmacopoeia Commission (EPC) has taken a significant step toward modern, animal-free testing by integrating recombinant Factor C (rFC) – a synthetic, validated solution – as one of the seven methods in general chapter 2.6.14. Bacterial endotoxins of the European Pharmacopoeia (Ph. Eur.). This milestone reinforces the commitment of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and of the EPC to patient safety, scientific rigour and sustainability under the 3Rs principle (replace, reduce, refine) and provides another valid alternative for users now that the rabbit pyrogen test has been suppressed (as of 1 January 2026).

To support stakeholders during the transition to rFC, the EDQM has published a comprehensive FAQ addressing common questions about rFC inclusion and future developments. The FAQ explains that rFC was adopted based on mature, evidence-backed data demonstrating equivalence to traditional limulus amoebocyte lysate (LAL) methods. Laboratories and manufacturers retain full method choice, guided by risk assessment and product suitability under chapter 5.1.13. Pyrogenicity.

The EDQM also clarifies its position on recombinant cascade reagents (rCR): while promising, these methods are still in the data-generation phase. The EPC encourages data generation to pave the way for future consideration of rCR. This approach ensures that innovation is embraced responsibly, balancing scientific progress with patient safety.

Harmonisation remains a priority. The inclusion of rFC aligns with ongoing dialogue within the Pharmacopoeial Discussion Group (PDG), enabling users to select methods that fit their regulatory and market requirements.

For more details, consult the full FAQ on the EDQM website. This resource aims to provide clarity, transparency and practical guidance as Europe leads the way in implementing validated, synthetic, animal-free solutions for bacterial endotoxin testing.

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