Wednesday 25 April 2018

Suppression of the Test for Abnormal Toxicity from the European Pharmacopoeia

During its 159th plenary session, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.).

As part of this exercise, 49 monographs revised to remove the test for abnormal toxicity were adopted by the Commission; notably, these included 36 monographs on vaccines for human use. In addition, as the general chapter Abnormal Toxicity (2.6.9) will no longer be referenced in any monograph, it will subsequently be rendered obsolete and will also be deleted from the Ph. Eur.

The Ph. Eur. Commission remains fully committed to the reduction of animal use wherever possible in pharmacopoeial testing, in accordance with the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes. The decision to suppress the test for abnormal toxicity at the 159th session of the Ph. Eur. Commission is a strong illustration of this commitment.

See: abnormal toxicity

Posted by Dr. Tim Sandle

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