Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
The ICH Q3E guideline is under development to promote international harmonization regarding the safety assessment and control of E&L, with reference to several documents that have been presented mainly by authorities and industries in Europe and the United States.
Step 2b draft guideline for consultation is expected to be available in November 2023.
Although, related guidelines in Japan have now been limited, it would be better to initiate preparation for future recommendations.
Current E&L assessment and control processes generally include: 1) obtaining information for Material and Component selection, 2) gathering structure and safety assessment information for substances from Extractables studies, and 3) testing and corresponding control of leachables.
Meanwhile, according to a part of the Concept Paper of the ICH Q3E guideline, there are at least following considerations as well as harmonization expectations related to quality control: 1) process and address material and component selection and characterization, 2) the conduct of E(&L) studies, 3) the design of an E&L control strategy based on science and risk-based principles.
In this presentation, such points are planned to be picked up and explained to the extent possible from the scene of guideline development.
