Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement.
Abnormal toxicity test
Batch release testing
Batch safety test
Target animal safety testing
Vaccines
Journal
Biologicals : journal of the International Association of Biological Standardization
ISSN: 1095-8320
Titre abrégé: Biologicals
Pays: England
ID NLM: 9004494
Informations de publication
Date de publication:
Jan 2020
Jan 2020
Historique:
received:
23
09
2019
accepted:
17
10
2019
pubmed:
9
11
2019
medline:
22
10
2020
entrez:
9
11
2019
Statut:
ppublish
Résumé
This one-day symposium organized by Humane Society International (HSI) brought together 18 international experts from Argentina, Brazil, China, Europe, India, Russia, South Africa and the United States to discuss the elimination of the abnormal toxicity test (ATT) from the testing requirements for human vaccines as well as the target animal batch safety test (TABST) and the laboratory animal batch safety test (LABST) for veterinary vaccines. Participants reported on country-specific regulatory requirements and, where present, the perspectives on waiver and elimination of those tests. In addition, the attendees, with HSI in the role of facilitator, moved to define the barriers to the complete elimination or waiving of these tests. This report expounds the outcomes of the symposium, and introduces a proposed roadmap - populated with country specific activities - for the elimination of these tests.
Identifiants
pubmed: 31699501
pii: S1045-1056(19)30113-7
doi: 10.1016/j.biologicals.2019.10.007
pii:
doi:
Substances chimiques
Vaccines
0
Types de publication
Clinical Conference
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
101-105Informations de copyright
Copyright © 2019.
Déclaration de conflit d'intérêts
Declaration of competing interest None.