China NMPA to Launch Cosmetic Adverse Reaction Monitoring System on October 1

China NMPA will launch the upgraded new version of the National Cosmetic Adverse Reaction Monitoring System on Oct. 1, 2022. Where cosmetic registrants, notifiers, entrusted production enterprises, operators, or medical institutions find or learn any cosmetic adverse reaction, they shall submit a report through the system.

Background

On Feb. 21, 2022, China National Medical Products Administration (NMPA) issued the finalized Measures for the Management of Cosmetic Adverse Reaction Monitoring (Measures), which will be implemented on Oct. 1, 2022. The Measures stipulates that cosmetic stakeholders (e.g. registrant, notifier, manufacturers, and operators) should take the initiative to collect and report adverse reactions of cosmetics through National Cosmetic Adverse Reaction Monitoring System, and cooperate with relevant regulatory authorities to investigate and handle the adverse reactions.

The Measures also clarifies the responsibilities and obligations of cosmetic stakeholders, and the detailed requirements for each stage in the monitoring and reporting of adverse reactions. Welcome to visit ChemLinked News for more details.

On Sep. 20, 2022, China NMPA issued an announcement stating that it will launch the upgraded new version of the National Cosmetic Adverse Reaction Monitoring System (hereinafter referred to as "system") on Oct. 1, 2022. ¹ Detailed information is as follows.

1. Enterprise Obligations

Starting from Oct. 1, 2022, where cosmetic registrants, notifiers, entrusted production enterprises, operators, or medical institutions find or learn any cosmetic adverse reaction, they shall submit the report through the system.

Where cosmetic operators and medical institutions do not currently have the conditions for online reporting, they shall submit a paper report to the local municipal- and county-level monitoring institutions, who shall submit the report online on their behalf.

Other units and individuals can report cosmetic adverse reactions to cosmetics registrants, notifiers and Chinese domestic responsible persons. They can also report to the local municipal- and county-level monitoring institutions or medical products administration departments, entrusting them to submit the report online on their behalf.

2. System Login

New users of the system can click on "Registration of Basic Institutions（基层机构注册）" on the system login page to submit an account application and fill in the relevant information. After approval, the user can log in to the system and report cosmetic adverse reactions.

Previously registered users can continue to use their account and password to log in to the new system and report cosmetic adverse reactions.

After the registered users log in to the system, they can view System User Operation Manual and the System Operation Video on the "Welcome（欢迎使用）" page of the system.

ChemLinked expects to assist companies in registering and notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at [email protected].

China NMPA to Launch Cosmetic Adverse Reaction Monitoring System on October 1

Background

1. Enterprise Obligations

2. System Login

Further Reading