Host: The Japanese Society of Toxicology
Name : The 47th Annual Meeting of the Japanese Society of Toxicology
Date : 2020 -
In November 2018, the European Medicines Agency (EMA) drafted a new EU Guideline on the Environmental Risk Assessment (ERA) of Medicinal Products for Human Use. The drafted new EU Guideline recommends a step-wise assessment consisting of a screening Phase I and testing Phase II (Tiers A and B). The step-wise assessment was already outlined in the current EU Guideline released in 2006, but some changes have been proposed in trigger values in assessment of persistence, bioaccumulation, and toxicity (PBT), and testing strategy in the sediment, terrestrial, and groundwater compartments in Phase II assessments in the drafted new EU Guideline; furthermore, the drafted new EU Guideline requires a tailored assessment for active substances with a specific mode of action such as antibiotics and endocrine active substances (EAS). The Japanese ERA Guidance, released by the Ministry of Health, Labour and Welfare (MHLW) in 2016, refers to the EU Guideline for the step-wise assessment; therefore, it is important to understand the concept of the new EU Guideline for development of a time-and-cost effective ERA scheme that suits environmental conditions in Japan. This poster presentation discusses the proposed changes of testing strategy in the drafted new EU Guideline, and possible influence on ERA in Japan by comparison of the ERA scheme between Japan and EU.
