A Cosmetics Adverse Reaction Monitoring System has been launched in China as part of the NMPA’s (National Medical Products Administration) drive to strengthen and improve the efficiency of monitoring adverse reactions to cosmetics nationwide. The new system also allows for analysis and evaluation on a national level.
China’s Cosmetics Adverse Reaction Monitoring System is an online platform used to report adverse reactions to cosmetics sold in China. The new system came online on October 1, 2022.
From October 1, 2022, cosmetic registrants, filers, entrusted manufacturers, cosmetics operators (such as online retailers or distributors), or medical institutions who discover or learn of adverse reactions to cosmetics, should report them through the new national cosmetic adverse reaction monitoring system.
Cosmetic operators or medical institutions who do not currently have an online account should report to the local city and county-level cosmetic adverse reaction monitoring agencies through paper statements, which will be submitted online on their behalf.
The general public may report adverse reactions to the cosmetic registrant/filer or the domestic responsible agent who will submit an online report on their behalf. The general public may also report to local city or county-level cosmetic adverse reaction monitoring agencies who again can submit reports online on their behalf.
How to create an account in the Cosmetics Adverse Reaction Monitoring System
In order to create a new account, click on Grassroots Institution Registration on the system login page (https://caers.adrs.org.cn/adrcos/) and complete the relevant information fields as prompted. Once the account application has been approved, registered users will be able to report cosmetics adverse reactions online.
As a reminder, adverse reactions are classified into three levels with corresponding regulatory measures to be carried out and reporting delays:
- General – report required within 30 days
- Serious – report required within 15 days
- Great Impact to the Community – report required within 3 days.
The new system has been developed to support the implementation of the Cosmetic Supervision and Administration Regulations (CSAR) of January 2021, and its subsidiary legislation, notably:
- Measures for the Supervision and Administration of the Production and Operation of Cosmetics (January 2022)
If you would like to know more about China’s cosmetics adverse reaction monitoring system or our services for cosmetics and ingredient registrations and filings, cosmetic ingredient codes, cosmetics GMP, QMS and SOP adaptation to China requirements, please contact us.