Back European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances

EDQM Strasbourg, France 10/04/2024
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European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances

At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) decided to engage on a path that should ultimately lead to the deletion of the general chapters on Histamine (2.6.10) and Depressor substances (2.6.11) from the European Pharmacopoeia (Ph. Eur.).

Both chapters describe tests that measure the effect of histamine and histamine-like substances, using guinea-pigs and cats respectively. They have been part of the Ph. Eur. since its first edition in 1977.

Today, Histamine (2.6.10) is referenced in the Production section of four monographs, while Depressor substances (2.6.11) is a stand-alone chapter. In addition, 10 other monographs have requirements – manufacturing process to eliminate or minimise substances lowering blood pressure – in their Production section that are remainders of these tests, although the chapters are not explicitly referenced.

In accordance with the European Convention for the Protection of Vertebrate Animals Used for Experimental and other Scientific Purposes and in order to pursue its constant efforts to replace, reduce and refine (3R principles) the use of animals for monograph requirements, the EPC has therefore elaborated a strategy to delete these animal tests and any direct and indirect references to them from the Ph. Eur. The rationale for this strategy is more fully discussed in the histamine strategy paper published in Pharmeuropa Bio & Scientific Notes.

The Ph. Eur. would like to encourage all stakeholders to take note of this document prior to consulting the relevant monographs that are now available for public consultation in Pharmeuropa 36.2 (consultation deadline 30 June 2024).

The complete deletion of general chapters 2.6.10 and 2.6.11 from the Ph. Eur. foreseen as of its 12th Edition would be a significant milestone in the elimination of animal tests from the Ph. Eur.

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