For quality control of vaccines, tests on animals are still required.

One of these tests is the laboratory animal batch safety test (LABST), better known in Europe as the 'abnormal toxicity test', which is performed on mice and guinea pigs.

Over 20 years ago, in 1997, the European Pharmacopoeia deleted the LABST for the quality control of veterinary vaccines due to its lack of scientific and regulatory relevance.

Although not used anymore in Europe, the LABST may still be requested by authorities in non-European countries not adhering to the European Pharmacopoeia. This important guideline paves the way for the waiving of this outdated test worldwide.

From November 2021 onwards, the new VICH guideline (GL59) will allow European manufacturers to apply for a waiver of the LABST when exporting to Japan and USA and regions or countries following VICH guidelines. Implementation of the guideline will therefore significantly reduce the number of animals used for batch release testing.