On August 6, 2021, the NMPA (National Medical Products Administration) announced the “Measures for the Supervision and Administration of Production and Operation of Cosmetics” to support the implementation of the CSAR (Cosmetics Supervision and Administration Regulation). The finalized regulation will be implemented on January 1, 2022.
General Provisions
According to the regulation, the registrants and filing persons should fulfill the obligation to:
- Establish a quality management system for production
- Monitor adverse events, manage risk control and product recall activities
- Account for product quality, safety and efficacy claims
Highlights
The person responsible for quality and safety should carry out the following duties for production management:
- Establish and organize the implementation of the quality management system;
- Review the product formulas, production processes, ingredient suppliers, etc.;
- Material release management and product release;
- Monitoring and management of cosmetics adverse events;
- Supervision and management of production activities of the contracted/entrusted production enterprises
Factory inspection must be qualified before selling into the China market and the retention of samples should be managed as below:
- Registrants or the filing persons shall retain the cosmetic samples and the original packaging
- The number of samples should meet the quality inspection requirements
- Sample retention period shall not be less than 6 months after the date of product expiration
Self-inspection on the production and quality management system should be conducted following the requirements below:
- Self-inspection report should cover the following items:
- Issues detected
- Product safety and quality assessment
- Rectification measures
- The retention period of self-inspection reports should be no less than 2 years.
- For cosmetics that stopped manufacturing for over 1 year:
- Domestic and overseas factories can start again for production only if self-inspection has been conducted and confirmed meeting the respective requirements
- After the production relaunch, domestic factories must submit the self-inspection report (and include any changes) to the respective MPA within 10 working days
By James Xu. Contact Cisema if you would like to learn more.
