Cosmetovigilance in China
China’s regulatory landscape for cosmetics is evolving, with a heightened focus on post-market oversight. Under the Cosmetic Supervision and Administration Regulation (CSAR), the National Medical Products Administration (NMPA) is increasing its attention on cosmetovigilance, requiring manufacturers to actively monitor and manage cosmetic product safety after market entry.
To ensure your cosmetic products remain compliant throughout their lifecycle, it is essential to have a comprehensive cosmetovigilance system in place. Cisema supports you with adverse reactions monitoring, regulatory documentation, and lifecycle reporting tailored to China’s expectations.
Understanding Cosmetovigilance Under CSAR
Cosmetovigilance refers to the structured monitoring of cosmetic product safety once products are available to consumers. In China, this includes a range of responsibilities placed on responsible persons to ensure traceability and consumer protection.
Obligations include:
These measures apply to both general and special cosmetic products, and failure to comply can lead to regulatory penalties, delisting from the market, or suspension of rights for commercial purposes.
The Critical Role of the Responsible Person in Cosmetovigilance
Meeting post-market obligations under CSAR requires the appointment of a legally designated responsible person, also known as the Domestic Responsible Agent. This person ensures the cosmetic product safety report is properly maintained, all undesirable effects are recorded, and any serious undesirable incidents are submitted promptly.
The responsible person is also tasked with:
Cisema can serve as your responsible person in China, ensuring full regulation compliance and fast response to all safety incidents.
Adverse Reactions
In May 2024, China’s NMPA finalized its guidelines on adverse reactions, reinforcing the need for accurate and timely reporting by registrants and manufacturers. All undesirable events linked to a cosmetic product must be assessed for severity and reported according to fixed timelines:
Severity Level
Description
Deadline
General Reactions
Mild irritation or discomfort under normal use
Within 30 days
Serious Undesirable Effects
Events involving hospitalization, congenital anomalies, or vital risk
Within 15 days
Social Impact Events
High-profile cases affecting human health or media coverage
Within 3 days
General Reactions
Description
Mild irritation or discomfort under normal use
Deadline
Within 30 days
Serious Undesirable Effects
Key Goal
Events involving hospitalization, congenital anomalies, or vital risk
Applies To
Within 15 days
Social Impact Events
Key Goal
High-profile cases affecting human health or media coverage
Applies To
Within 3 days
Submissions must include product batch, symptoms affecting the human body (including mucous membranes, oral cavity, external parts, and external genital organs), investigation findings, and a risk evaluation.
Companies are also required to store records for at least three years and must maintain corrective measures and documentation to resolve ongoing safety issues.
Daily Monitoring of NMPA’s Adverse Event Monitoring System
To protect consumers and ensure compliance, Cisema conducts daily checks of China’s NMPA adverse event monitoring platform. This allows us to:
This proactive approach ensures consumer safety, strengthens cosmetic product safety, and enhances your brand’s reputation in the Chinese market.
Cisema’s Cosmetovigilance Services
We offer full lifecycle support for your cosmetovigilance obligations in China:
1
System Design
2
Intake & Reporting
3
Investigation & Records
4
Education & Compliance
Why Choose Cisema?
Request a Proposal for Cosmetovigilance Services
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