JRC scientists supported the development of two guidelines released by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) on the harmonisation of criteria to waive target animal batch safety tests for inactivated [GL(50)R] and live [GL55] veterinary vaccines. Their implementation (from May 2018 onwards) is a major step towards international harmonisation and will reduce the number of animals used for batch release testing. The JRC's EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has been working on behalf of EMA with VICH experts on the development of these guidelines.
Each batch of a vaccine has to undergo strict quality control before it is released on the market. Some of these batch release tests are carried out in animals, for example the target animal batch safety test (TABST). Since 1st April 2013, the TABST is no longer required in Europe and has been deleted from the European Pharmacopoeia monographs for veterinary vaccines. However, outside of Europe and European Pharmacopoeia countries the TABST is still requested for batch release. With the new VICH GL55 and the revised GL50(R), European manufacturers have the possibility to apply for a waiver of the TABST when exporting to the other VICH regions (Japan, North America) or countries following the VICH guidelines.
EURL ECVAM had been a driving force for this change by following up the questionable relevance of the target animal batch safety test as postulated for many years by European control authorities and manufacturers. In 1997, EURL ECVAM launched a retrospective study analysing TABST data provided by manufacturers and control authorities. The ECVAM Scientific Advisory Committee (ESAC) peer-reviewed the results of the study and stated in 2002 that the TABST was no longer relevant and should be omitted for routine batch control.
This had been incorporated into the European Pharmacopoeia and from 2004 onwards (until its deletion in 2013) manufacturers had the possibility to waive the TABST provided that their vaccines fulfilled the waiving criteria, i.e. the manufacturer had to demonstrate to the control authorities that at least 10 batches of the given product had not failed the TABST.
- Publication date
- 31 May 2017