China Toothpaste Filing and Registration

Definition

Toothpaste refers to solid and semi-solid preparations designed to clean, beautify, and protect the surfaces of human teeth and surrounding oral tissues through friction.

Regulatory Overview

According to current regulations, toothpaste is regulated as a general cosmetic product. Before market launch, the product must undergo filing procedures in accordance with relevant requirements.

Based on efficacy evaluations conducted in compliance with national and industry standards, toothpaste registrants may claim benefits such as caries prevention, dental plaque inhibition, dentin sensitivity resistance, and relief of gum problems.

Relevant Regulatory Basis

• Regulations on the Supervision and Administration of Cosmetics

• Measures for the Supervision and Administration of Toothpaste

• Provisions on the Management of Toothpaste Filing Information (Draft for Comment)

• Measures for the Supervision and Administration of Cosmetic Labels

• Catalogue of Raw Materials for Toothpaste (Under Collection)

• Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)

Toothpaste Filing Process

1. Apply for a filing account

2. Determine product formula and label

3. Conduct sample testing

4. Organize other required documents

5. Submit filing materials via the National Medical Products Administration (NMPA) Information Service Platform

6. Upload a summary of product efficacy claims on the NMPA-designated website

7. Complete the filing process

8. Annually report production status and compliance with laws, regulations, mandatory national standards, and technical specifications to the responsible drug administration (similar to the cosmetic annual report).

Information Required for Filing Account Application

(1) Information form of the filer and resume of the quality safety responsible person
(2) Overview of the registrant’s quality management system
(3) Overview of the registrant’s adverse reaction monitoring and evaluation system
(4) For overseas filers: information form of the domestic responsible person
(5) For overseas filers: original letter of authorization for the domestic responsible person and notarized certificate
(6) If the filer has independent production or entrusts an overseas manufacturer: production enterprise information form and resume of the quality safety responsible person; existing production enterprises and related information must be submitted at one time. For overseas manufacturers, original certification materials of production quality standards are required.

Domestic enterprises engaged only in entrusted production must submit the production enterprise information form and the resume of the quality safety responsible person as specified in item (6) to establish and confirm the entrusted production relationship.

Entities with multiple roles (e.g., domestic registrant, domestic responsible person, production enterprise, or multiple overseas registrants under the same domestic responsible person) may submit all relevant materials at once. After review, corresponding user permissions will be granted. Existing users may supplement information and expand permissions as needed.

Information Required for Product Filing

(1) Toothpaste Filing Information Form and related materials
(2) Basis for product naming
(3) Safety information of raw materials used in the product formula
(4) Product implementation standards
(5) Sample product label
(6) Product test report
(7) Product safety assessment data
(8) For imported toothpaste: certificate of free sale abroad

Additional Requirements:

(1) Upload a summary of the basis for product efficacy claims on the NMPA-designated website during filing
(2) Annually report production status and compliance with laws, regulations, mandatory national standards, and technical specifications to the responsible drug administration.