The OECD has initiated the development of a document that reviews the state of the art using human iPSC technology in the development of new methods for regulatory toxicology. The aim is to highlight the steps needed to integrate this emerging technology into regulatory toxicology frameworks. The review will assess the maturity of this technology for regulatory testing, addressing key aspects such as availability, stability, performance, advantages, and limitations. This document also aims at an application to the evaluation of liver toxicity using hiPSC based-liver organoids test methods.

Currently, liver toxicity assessment relies on animal testing. This document will explore the development of alternative methods, particularly those based on liver organoid models and iPSC-derived systems, for regulatory testing. Compared to primary human hepatocytes, iPSC-derived hepatocytes exhibit key functional characteristics that closely resemble those of primary cells. These features make them a promising alternative for use in regulatory testing. The objective of the document is also to examining which methods are best optimised for standardisation.

The presentation will provide an overview of the OECD Test Guidelines Programme and its objectives. It will outline the key components and current status of the ongoing project. It will also explore potential other applications of iPSCs within the programme and discuss the main challenges ahead, including those related to validation and regulatory acceptance.