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Guidance on Multiple Safety Data Combination Assessment System for Single Dose Toxicity Assessment of Quasi-drugs and Cosmetics
Local Title:
医薬部外品・化粧品の単回投与毒性評価のための複数の安全性データを組み合わせた評価体系に関するガイダンスについて
Country/Region:
Japan
Competent Authority:
Ministry of Health, Labour and Welfare
Type:
Regulation
Status:
In force
Release Date:
2021-04-22
Implementation Date:
2021-04-22
Document
Language Source Title Access
JA
 Official Guidance on Multiple Safety Data Combination Assessment System for Single Dose Toxicity Assessment of Quasi-drugs and Cosmetics (JP)
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Summary

On April 22, 2021, Japan’s Ministry of Health, Labour and Welfare (hereafter referred to as MHLW) issued a technical guidance for single dose toxicity assessment of quasi-drugs and cosmetics. In this document, MHLW summarizes the process of evaluating single dose toxicity evaluation by Weight of Evidence (normally abbreviated as WoE) combining safety data including data from 3T3-NRU cytotoxic test.

Noteworthy Information