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China Finalizes Detailed Dossier Requirements for Toothpaste Notification

Nov 23, 2023
Winnie Xu
The Provisions for Management of Toothpaste Notification Dossiers will become effective on December 1, 2023, marking the era of strict supervision in China's toothpaste market.

Under the new regulation, children's toothpaste, toothpaste containing new ingredients, as well as toothpastes with the efficacy of preventing caries, inhibiting dental plaque, resisting dentin hypersensitivity, and alleviating gum-related problems, are key categories of supervision.

On November 22, 2023, China National Medical Products Administration (NMPA) unveiled the definitive edition of the Provisions for Management of Toothpaste Notification Dossiers (the Provisions). Shaped by two rounds of public consultations in January 2021 and September 2023, this final version is set to be enforced from December 1, 2023. Comprising 3 chapters, 32 articles, and 3 annexes, the Provisions specifies the responsibilities and obligations of toothpaste notifiers, the user-information-related dossiers, and the necessary documentation for initial toothpaste notification, etc.

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Tags : Chinese MainlandPre-market ApprovalLabeling/Claim/AdvertisingCSARToothpaste
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