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
Document
Language Source Title Access
ZH
Official Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial)
ChemLinked Translation
Guidelines for Collection and Reporting of Cosmetic Adverse Reactions by Cosmetic Registrants and Notifiers (Trial)
File Language : EN
$ 115
Summary

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.

History
2024-04-19
Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial)
In force
Release Date: 2024-04-19
Implementation Date : 2024-04-19
2022-11-25
Noteworthy Information
User Guide