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NMPA Announcement on Issuing the Provisions for Notification Dossiers of Toothpastes

Toothpaste Filing Regulation

On November 22, China's National Medical Products Administration (NMPA) issued the Provisions for Notification Dossiers of Toothpastes (hereinafter referred to as the Provisions), which will come into effect as of December 1, 2023. From then on, toothpaste under application for filing shall provide all required materials.

There are three chapters and thirty-two articles in the Provisions, which provide detailed descriptions of toothpaste filers, user information, toothpaste filing information, children's toothpaste, efficacy evaluation, etc.

Required filing materials

1). Name, address, contact information of the filing person;

2). Name, address, contact information of the production enterprise;

3). Product name;

4). Product formula;

5). Product implementation standard;

6). Product label template;

7). Product inspection report;

8). Product safety assessment materials.

Children's toothpaste

Children's toothpaste refers to the toothpaste that is applicable to children under the age of 12 (including 12 years old). The claimed efficacy categories of children's toothpaste are limited to cleansing and caries prevention.

Products that use words such as "适用于所有人群 (applicable to all people)", "全家使用 (available for all family members)" or use trademarks, patterns, homophonic expressions, letters, Chinese Pinyin, numbers, symbols, packaging forms, etc. to imply that the use group includes children shall be managed as children's toothpaste.

Toothpaste efficacy claims

Toothpaste claims to have anti-caries, dental plaque inhibition, anti-dentin sensitivity, gum problems relief, and other efficacy, the human efficacy evaluation is required to carry out; toothpaste only claims to have cleansing efficacy can be exempt from efficacy evaluation; for those that achieve anti-caries by adding fluoride, and fluoride meets the "test item requirements", they can be exempt from the anti-caries efficacy evaluation.

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