Deletion of Target Animal Batch Safety Test

Topic: Quality control of vaccines

Test Method Number:
TM1997-01 (EU)
Short Name of TM:
Year received:
Responsible Organisation:
General Comments:

Method Description

Since 1st April 2013, the TABST is no longer required in Europe and has been deleted from the European Pharmacopoeia monographs for veterinary vaccines. Since 2005, the target animal batch safety test could be waived when a sufficient number (e.g. 10) of batches had been found to comply with the test.
International - VICH: Two VICH guidelines on harmonisation of criteria to waive target animal batch safety testing for inactivated (VICH GL50R) and live (VICH GL55) vaccines for veterinary use are in force since in May 2017 and should be implemented by May 2018. An earlier version of VICH GL50R had been in force since 2013. By meeting the requirements outlined in VICH GL50R and 55, vaccine manufacturers can now apply for a waiver of the TABST by their national competent authorities.

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