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Under CSAR framework, cosmetics registrants and notifiers are required to submit product safety assessment documents during registration and notification. Until May 1, 2024, they have the option to submit a simplified safety assessment report. However, from May 1, 2024 onwards, the full version of the assessment report must be submitted.
Considering industry challenges, China's National Medical Products Administration (NMPA) has extended the transition period. Registrants and notifiers can still submit a simplified safety assessment report before May 1, 2025, as long as the assessment was started before May 1, 2024.
To guide companies, in April 2024, NMPA issued several new regulatory documents related to safety assessment. This includes guidelines that classify submission requirements based on risk management principles and provide self-examination points for the assessment reports.
With these supporting policies and optimization measures, the full safety assessment report system can be effectively implemented in China's cosmetics industry. ChemLinked invited an experienced regulatory specialist, Inna Fu from REACH24H, to explain the requirements for cosmetic safety assessment in China and highlight important regulatory updates and changes.
Notes:
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