On 21 Feb 2022, China National Medical Products Administration (NMPA) issued the “Measures for Monitoring Adverse Reactions of Cosmetics”. It will come into force from 1 Oct 2022.
The Measures defines three adverse reactions types based on the damage caused by the cosmetic products. They include,
- A normal adverse reaction is a reaction to cosmetics that involves lesions of the skin or accessory organs in addition to systemic or partial damage to the body.
- Serious cosmetic adverse reactions refer to the reactions include one of the following damages:
- Causes temporary or permanent loss of function, such as persistent non-healing of skin lesions, scarring, permanent hair loss, obvious changes in damage, etc.;
- Causes systemic damage to the human body, such as abnormal liver and kidney function, anaphylactic shock, etc.;
- Resulting in hospitalization or the medical institution deems hospitalization necessary;
- Causing other serious damage to the human body, endangering life, or causing death.
- Cosmetic adverse reactions that may cause greater social impact, refer to in a certain area, because of using the same cosmetic product, cause serious damages to many people.
The measures require both local companies and overseas companies to establish their own monitoring systems.
Contact RegASK to get prepared for potential cosmetics regulatory changes in China.
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