The European Pharmacopoeia (Ph. Eur.) is setting groundbreaking standards in pyrogen testing by abolishing the traditional rabbit pyrogen test (RPT). This decision is setting new ethical benchmarks and promoting the development of innovative in vitro alternatives such as monocyte activation tests (MAT).
Pyrogen tests without rabbits: the European Pharmacopoeia is dispensing with animal testing
11.07.2024
Since the 1940s, testing on rabbits has been the standard method for detecting pyrogens in pharmaceutical products intended for injection, infusion or implantation in humans. This method involves administering the substance to be tested to rabbits intravenously to determine whether their body temperature increases, which may indicate the presence of pyrogenic substances; these are substances that induce fever and could lead to severe health problems in patients.
Since it first appeared in the Ph. Eur. in 1986, testing in rabbits has been established as the most common method of pyrogen testing. Despite its historic significance, for many years now the Swiss delegation in the European Pharmacopoeia Commission has been campaigning in favour of replacing RPT with more innovative – and above all more ethical – in vitro alternatives.
Since 1986, the European Pharmacopoeia Commission has been working continuously to implement its 3Rs strategy (Replacement, Reduction, Refinement) and to develop alternative methods. In 2021, the Commission decided to completely replace RPT with advanced in vitro testing, such as the monocyte activation test (MAT), within five years.
At its 179th session in June 2024, the European Pharmacopoeia Commission approved the removal of rabbit testing from all provisions. The revised texts will be published in Supplement 11.8 of the European Pharmacopoeia and will come into effect on 1 July 2025. This means that the use of RPT will no longer be required in any texts of the European Pharmacopoeia. These developments represent a significant step forward in terms of animal welfare, and will send out a strong message across the world.
The Ph. Eur. is elaborated under the aegis of the Council of Europe. The European Pharmacopoeia Commission, made up of delegations from the member states, is responsible for its elaboration. The Swiss delegation consists of three members and is led by the Head of Swissmedic's Pharmacopoeia Division.
Like other states, Switzerland also has its own pharmacopoeia: the Swiss Pharmacopoeia (Pharmacopoeia Helvetica, Ph. Helv.). The texts of the Ph. Eur. form the basis of the Ph. Helv. The Swiss Pharmacopoeia also includes provisions that are only relevant to Switzerland.
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