Europe – EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals

The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents. The ECBS recommendations, issued at the Committee’s 69th meeting, are based on the consideration that the omission of the abnormal toxicity test would not compromise the quality and safety of vaccines and other biological products.

The European Pharmacopoeia (Ph. Eur.) Commission endorsed the complete
suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph.
Eur.) in November 2017. As part of this exercise, 49 monographs were revised to
remove references to the test for abnormal toxicity and it was decided to completely
suppress general chapter AbnormalToxicity(2.6.9), as it would no longer be referenced
in the Ph. Eur. The decision is reflected in Supplement 9.6 of the Ph. Eur. and will
become effective as of 1 January 2019. This testifies to the commitment of the EDQM
and of the Ph. Eur. Commission to reduce the use of animals in pharmacopoeial testing,
in line with the Council of Europe’s Convention (ETS 123) for the Protection of
Vertebrate Animals used for Experimental and other Scientific Purposes.
The international dimension brought in by the WHO Expert Committee was welcomed
by Susanne Keitel, Director of the EDQM: “The ECBS recommendation reflects today’s
globalised dimension of medicines production and gives international prominence to the
need to question and, wherever possible, replace the use of animals to test modern
medicines”.
Animal tests such as the abnormal toxicity test were developed for the safety testing of
human vaccines at a time when limited scientific knowledge for the quality control of
biological products existed. Over the past decades, the strenuous work of the Ph. Eur.
Commission and its counterparts at global level has allowed for the identification of
viable alternatives to the use of animals for tests, while still ensuring high levels of
protection for human health. In particular, today’s manufacturing processes, including
the Good Manufacturing Practices (GMP) and in-process quality controls, can ensure a
more appropriate level of quality and safety for vaccines and other biological products
than the abnormal toxicity test…