Host: The Japanese Society of Toxicology
Name : The 49th Annual Meeting of the Japanese Society of Toxicology
Date : June 30, 2022 - July 02, 2022
Prior to S11, nonclinical safety testing guidelines for pediatric drug development had been implemented by FDA (2006), EMA (2008), and MHLW (2012). Although it is stated that specific aspects of the design of juvenile toxicity studies are outside the scope, ICH-M3 (R2 2010) and Q&As (2012) have been internationally agreed on as nonclinical safety testing guidelines for pediatric drug development. Since there had been multiple guidelines that differ from region to region, the requirements and study designs from the regulator of each country differed. Another issue was that the criteria for conducting juvenile animal tests were not clear. In particular, the decision to conduct non-clinical studies using juvenile animals has a great impact on the drug development schedule, so harmonization on nonclinical safety testing for pediatric drug development was desired. At long last, the guideline was harmonized and S11 nonclinical safety testing in support of development of pediatric pharmaceuticals was implemented 2021 by MHLW/PMDA. It is expected that various problems related to pediatric drugs will be sorted out, and then the development of pediatric drugs will be promoted. On the other hand, certain points are still at issue. The Weight of Evidence approach conducts Juvenile animal study according to the characteristics of the identified safety concerns, but also supposed to be considers other type of studies, such as in vitro and ex vivo. As the core part is relatively a conceptual description, reality and their usefulness being to be revealed by non-clinical studies conducted along with S11 accumulated now and in the future. In this workshop, I would like to share the issues that need to be addressed from now on.
