China: Implementation of Toothpaste Regulatory Regulations and Simplification Filing Requirements

The National Medical Products Administration (NMPA) announced the implementation of the requirements of toothpaste regulatory regulations and the simplification of filing requirements for toothpaste on the market.

Firstly, NMPA emphasizes the responsibilities of the filing person (toothpaste filer) should be an enterprise or an established organization complete with a quality management system and adverse reaction monitoring and evaluation system. Starting from 1 December 2023, prior to being marketed or imported, domestic toothpaste is required to be registered under the provincial drug regulatory department, where the recorder is located, and the imported toothpaste must be registered with the State Food and Drug Administration.

The responsible toothpaste filer, specifically for the first-time registration filer, should note the requirements:

• For the first-time product to be registered, the filer is required to submit registration information via the toothpaste registration information service platform that has been designed by the registration management department.

• To be responsible for the safety, quality, efficacy claims of the toothpaste, integrity, authenticity, and traceability of the product registration materials and data.

• To upload and publish the summary of the product efficacy evaluation data on the efficacy claims on the filing platform and must respond to accept for social supervision. However, this requirement is exempted for toothpaste with the claim of cleaning effects only.

• Ensuring the children's toothpaste claimed suitable for under 12 years old (including 12 years old) provide claims only for cleaning and caries prevention, marked with the children’s toothpaste logo (“Children’s Toothpaste”) on the sale packaging, and marked with relevant warnings (“Use under adult supervision”, “Not edible”, “Beware of swallowing”)

Next, for the safety risks assessment, starting from 1 October 2023 until 30 November 2023, toothpaste filers can submit the following simplified information for toothpaste that has been on the market:

• The toothpaste filer information (name, address, contact information)

• The assigned production information (name, address, contact information)

• Product information (product name, product formula, product sales packaging label pictures)

• Relevant information confirming the safe use history of the product (production input records, material records, sales invoices, inspection reports)

In the case of toothpaste products whose first batch was sold in the market prior to 1 January 2021, the filer may keep the product registration documentation on file for future use. Otherwise, the filer must upload complete filing documents via the filing platform.

For toothpaste products with simplified filling, the labeling must adhere to the "Measures for the Administration of Cosmetic Labels" and any labeling revisions must be made before 1 July 2024. The product registration materials and summary of the product cleaning efficacy claims must be completed, uploaded, and published before 1 December 2025. All responsible persons are advised to be prepared with the requirements and note the important dates to prevent market disruption.

Source: National Medical Products Administration (NMPA)

Contact us at info@arqon.com for more information.