Global Cosmetic Compliance
Intelligence & Solutions

Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial)

Local Title
化妆品注册人、备案人化妆品不良反应收集和报告指导原则(试行)
Country/Region
Chinese Mainland
Competent Authority
National Center for Adverse Drug Reaction (ADR) Monitoring
Type
Regulation
Status
In force
Release Date
2024-04-19
Implementation Date
2024-04-19

ChemLinked Translation

Guidelines for Collection and Reporting of Cosmetic Adverse Reactions by Cosmetic Registrants and Notifiers (Trial)
File Language: EN
115
Translation document cover preview

On November 25, 2022, the Center for Drug Reevaluation and the National Center for Adverse Drug Reaction (ADR) Monitoring of China published the draft of Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial) for public feedback. On April 19, 2024, the finalized version of the Guidelines was released.

The Guidelines provides instructions for registrants and notifiers on the collection and reporting of cosmetic adverse reactions, including stages from collection, recording, transmission, to report confirmation, analysis and evaluation, submission, quality control, and record management.

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