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On September 26, 2025, China’s National Medical Products Administration (NMPA) issued a draft Announcement on Matters Concerning Toothpaste Notification Management for public consultation. 1 The proposal seeks to ease the regulatory burden on industry by allowing proof of safe use history to substitute for toxicology test requirements for existing toothpaste products. Comments can be submitted to [email protected] before October 26, 2025.
Toothpaste is currently regulated by reference to general cosmetics. Under NMPA Announcement No. 124 of 2023, companies with existing products were permitted to complete a simplified notification during the transition period. However, they must still supplement a full notification dossier by December 1, 2025. The new draft announcement aims to further streamline this process for products with an established safety record.
Proposed Changes
The draft introduces targeted exemptions from toxicology testing based on product market history:
1) For toothpaste products notified under the simplified process, notifiers may submit “proof of safe use history” in place of full toxicology test reports. This recognizes the safety profile of products that have been produced, sold, and used over time.
2) Products launched on or after January 1, 2021 may be exempted from submitting oral mucosal irritation test reports if the notifier provides:
A product safety assessment report;
A declaration of safe use history, including production and sales volumes, records of any quality or safety incidents, and adverse reaction monitoring data.
If adopted, the proposal would provide regulatory relief for the toothpaste sector by reducing time and costs for products with a demonstrated safety track record.
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