Vaccines for Veterinary Use: A step further on the 3Rs path

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Vaccines for Veterinary Use: A step further on the 3Rs path

Contributor: Sherry Ward, AltTox

Source: European Pharmacopoeia News

10 March 2016

As part of the Ph. Eur. Commission’s efforts to replace in vivo with in vitro methods, around 40 inactivated vaccine-specific monographs and the general monograph Vaccines for veterinary use (0062) were adopted at its 153rd Session in November 2015. These texts will be published in the 9th Edition and shall be effective from 1st January 2017. This is the result of the continued and active involvement of the Ph. Eur. Commission in the replacement, reduction, and refinement of animal testing (3Rs) and fully in line with the EDQM’s mission to promote and protect human and animal health.

Read the Press Release: “Vaccines for Veterinary Use adopted by the European Pharmacopoeia at the 153rd Session for publication in the 9th Edition – A new step on the 3Rs path”

After harmonising the technical requirements for the registration of veterinary vaccine products to align them with VICH guidelines 41 and 44 and deleting the target animal batch safety test (TABST) from the European Pharmacopoeia for all veterinary vaccines – in force since 1st April 2013(1), resulting in a considerable reduction in testing on animals (2) – the EDQM is pleased to announce that a new stage has been reached on the 3Rs way….