Deletion of Target Animal Batch Safety Test

Topic: Quality control of vaccines

Test Method Number:

TM1997-01 (EU)

Short Name of TM:

TABST

Year received:

1997

Responsible Organisation:

EURL ECVAM - European Union

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.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment	Documents/Links
Jan 1997	Not applicable	See validation step.

Validation

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Date	Stage	Comment	Documents/Links
Jan 1997	Planning	Launch of the EURL ECVAM retrospective analysis of TABST data. The study was carried out by the Advisory Group on Alternatives to Animal Testing in Immunobiologicals (AGAATI) on behalf of EURL ECVAM (contract 134 10-97-11F 1 EI ISP NL).
Jan 2001	Finalised	Final report of the study contract No 134 10-97-11 F 1EI ISP NL sent to EDQM and EMA	Publication

Peer-review

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Date	Stage	Comment	Documents/Links
Jun 2002	Finalised	ESAC peer reviewed the retrospective analysis and issued the statement at the 18th ESAC plenary meeting.	ESAC Statement Documents provided to ESAC

Recommendation

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Date	Stage	Comment	Documents/Links
Apr 2004	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Apr 2004	Drafting of new regulatory standard/guideline	European Pharmacopoeia: allows waiver of the TABST for established vaccines
Apr 2012	Revision of existing regulatory standard/guideline	European Pharmacopoeia: deletion of the TABST for veterinary vaccines coming into force on 1 April 2013	EDQM document
Mar 2013	Adopted/published	VICH: allows waiver of TABST for inactivated veterinary vaccines (GL50)	VICH Guideline
Mar 2018	Adopted/published	VICH: allows waiver of TABST for inactivated (GL50R) and live veterinary vaccines (GL55)	VICH guidelines