European Pharmacopoeia Goes Digital

On June 24, 2025, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced that the 12th edition of the European Pharmacopoeia (Ph. Eur.) will be released as an all-digital, redesigned, user-friendly platform that will allow users to stay connected with quality standards via a 365-day license (1).

EDQM will host a two-part webinar to present the benefits of the new platform. “Unlocking the Potential of the European Pharmacopoeia Online will be held on July 1, 2025 with another session to be presented on July 3. Module 1 will discuss new features, advanced navigation, and searching options. Module 2 will discuss license activation and user management. Information on how to register for the free webinars can be found on EDQM’s website. License information for the new digital edition is also available at the site.

The Ph. Eur. provides legally binding standards from a legal and scientific basis for the quality control of drugs and drug ingredients in the European Union.These standards must be applied to marketed medicinal products in the EU.

RPT phase out
In other EDQM news, the organization’s podcast EDQM on Air released an episode discussing the phase out of the rabbit pyrogen test (RPT). The RPT is a safety test used to determine if pyrogens are present in medicines. More than 400,000 rabbits are used worldwide, according to EDQM, to perform the test. EDQM has been promoting the use of alternative tests and removed the RPT in June 2024 from Ph. Eur. texts. In the podcast, Gwenaël Cirefice and Emmanuelle Charton explain how EDQM is committed to animal welfare in Europe (2).

The limitation of animal testing has also been promoted in the United States. In July 2024, the United States Pharmacopeia (USP) announced it was permitting the use of non-animal-derived reagents for endotoxin testing (3).Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discussed the new USP chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, and how it will impact industry in the November 2024 episode of PharmTech’s Ask the Expert video series (4).

Perspectives on the USP chapter

“Twenty years ago, the predominant test procedure for determining endotoxin level, or pyrogen level, as we called it, was the rabbit test. And we used to actually inject rabbits, which was very subjective because you'd measure their temperature,” Schniepp said in the episode. “And then we evolved to using the limulus amoebocyte lysate or LAL test, and there was the chromogenic [test] but they were all predicated off the horseshoe crab. So now we're moving forward to reagents for this test, which is critical to the release of sterile injectables that does not involve animals. So absolutely, we should consider this.”

“I think it is also worthwhile mentioning that what is happening in the US is mirrored in other jurisdictions, for example, when you look at the European Medicines Agency [EMA], they support the use of animal free cell culture reagents as part of its efforts to reduce animal use in medicine testing,” Schmitt added. “We don't want to use rabbits. We don't want to use horseshoe crabs, and it's EMA’s innovation task force that encourages that use of alternative methods to animal models, and that, what they say is, will improve the scientific quality and also, of course, animal welfare.”

Nicola Reid, associate director of Product Management, Endotoxin Products at Charles River Laboratories, also provided her perspective on the USP chapter in an interview with Pharmaceutical Technology® (5). “When [endotoxins] do end up in a final product, [and] when that [product] is injected or implanted into a patient, it can lead to what we call a pyrogenic response,” Reid explained. “What that means is the human body is reacting to this contaminant, and it can cause anything from a mild fever all the way through to death. That's the ultimate circumstance of too much endotoxin. So, therefore, most pharmaceutical products that are tested for endotoxin are those that are injectable or implantable and come into contact with the bloodstream, and therefore have to have low levels of endotoxin.”

References

1. EDQM. All-Digital 12th Edition Marks a New Era for the European Pharmacopoeia. Press Release. June 24, 2025.
2. EDQM. EDQM On Air–A Win for Animals–Phasing Out the Rabbit Pyrogen Test. Press Release. June 19, 2025.
3. USP. Expert Committee Approves Endotoxin Testing Using Non-Animal Derived Reagents. Press Release. July 26, 2024.
4. Thomas, F. and Haigney, S. Non-Animal-Derived Reagents for Endotoxin Testing. PharmTech.com. Nov. 21, 2024. https://www.pharmtech.com/view/non-animal-derived-reagents-for-endotoxin-testing
5. Haigney, S. The Impact of USP Chapter <86> on Endotoxin Testing. PharmTech.com. Dec. 11, 2024. https://www.pharmtech.com/view/the-impact-of-usp-chapter-86-on-endotoxin-testing