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
Status:
In force
Type:
Regulation
Release Date:
2021-04-22
Implementation Date:
2021-04-22
Competent Authority:
Ministry of Health, Labour and Welfare
Document:
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.

Details
Log in to Access More Information
LOG IN
Not a member yet? Sign up here.
hide
Document
Original Language
Log in to access the document
LOG IN
Not a member yet? Sign up here.