CSAR Subsidiary Regulations: Draft Regulations on Cosmetic Adverse Reaction Monitoring Unveiled

Regulatory authorities

NMPA, provincial and local MPAs

Responsible for the supervision and management of cosmetic adverse reaction monitoring

Monitoring agencies

National, provincial, and local monitoring agencies

Responsible for the technical work of cosmetic adverse reaction monitoring

Main bodies of cosmetic production and operation activities

Registrants, notifiers, domestic responsible persons, entrusted production enterprises, cosmetic operators, e-commerce platforms, beauty salons, medical institutions, etc.

Shall fulfill the reporting obligations of cosmetic adverse reactions

Adverse Reaction Collection

Cosmetics registrants, notifiers, and domestic responsible persons shall publish their contact information such as telephone number and e-mail address, designate a contact person, and actively collect information on adverse reactions from the entrusted cosmetic production enterprises, operators, etc.

Adverse Reaction Monitoring

1. Reporting principles

Cosmetic adverse reactions shall be reported following the principle of immediate reporting on suspicion, that is: suspected cases of human damage related to cosmetics can be reported as cosmetic adverse reaction information.

2. Reporting approaches

• Cosmetic stakeholders can register as a user of the National Cosmetic Adverse Reaction Monitoring Information System and report adverse reactions online;

• Cosmetic operators that currently do not have the capacity for online reporting can report to the local monitoring agency in hard copy, and the agency will report online on their behalf.

Adverse Reaction Analysis and Evaluation

Cosmetic registrants and notifiers shall analyze and evaluate the adverse reaction reports collected, conduct self-inspection of the adverse reactions’ possible causes in terms of the product formula, production process, GMP and etc., and conduct on-site verification when necessary.

Adverse Reaction Investigation and Risk Control

If a product is found to have safety risks and may endanger human health, risk control measures such as suspension of production and sales of related products, product recall, modification of label and leaflet, improvement of production processes, and changes of registration or filing shall be adopted.

Adverse Reaction Monitoring Information Management

Cosmetics registrants, notifiers,  domestic responsible persons, and other relevant enterprises shall establish and keep cosmetic adverse reaction monitoring records or report records. These records shall be kept for at least 1 year after the expiry of the product shelf life; for products whose shelf life is less than 1 year, the corresponding records shall be kept for at least 2 years.

The adverse reaction monitoring record shall include at least the name, symptoms, or signs of the reporter or the person who has the adverse reaction, the type of the adverse reaction, the   date of the adverse reaction, and the name of the cosmetics used.