Global Cosmetic Compliance
Intelligence & Solutions

Immunotoxicity Test (Draft) and Drafting Instructions

Local Title
免疫毒性试验方法(征求意见稿)及起草说明
Country/Region
Chinese Mainland
Competent Authority
National Institutes for Food and Drug Control
Type
Regulation
Status
Invalid
Release Date
2025-01-22
Implementation Date
/

On January 22, 2025, China National Institutes for Food and Drug Control (NIFDC) released nine testing methods for public consultation, with feedback accepted until February 21, 2025. One of the methods is the Immunotoxicity Test (Draft).

This method is formulated with reference to S8 Immunotoxicity Studies for Human Pharmaceuticals by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Guideline on Repeated Dose Toxicity by the European Medicines Agency (EMA), etc. It provides the principles, requirements, and procedures for conducting immunotoxicity tests, aiming to assess the likelihood of immunotoxicity reactions in cosmetic ingredients. 

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