Sunday, 31 May 2020

Tetanus vaccines

The Ph. Eur Commission adopted 16 revised monographs on tetanus vaccines, following a reassessment of toxicity testing requirements. The revisions include the suppression of three tests and the harmonisation, as far as possible, of the Ph. Eur.’s toxicity testing requirements for tetanus vaccines for human and veterinary use. The Ph. Eur. Commission is committed to phasing out the use of animal tests by continuously reviewing in vivo tests described in Ph. Eur. texts and applying, whenever possible, the 3Rs principles set out in the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (ETS No. 123). The reassessment of toxicity testing requirements for tetanus vaccines and the decision to delete three animal tests is an illustration of this commitment.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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