NMPA enforced Management Rules for Toothpaste Registration

The Chinese Supervision and Management Measures of Toothpaste Products has been enforced since 2023.12.1. To facilitate the enforcement of the Measures, NMPA published and enforced the Management Rules for Toothpaste Registration. This Management Rules will guide applicants with relevant registration requirements and procedures.

There are three chapters and three annexes in this Rules. Chapter one gives general information on toothpaste registration. Chapter two illustrates the required documents, the applicants and agent’s conditions, renewal of information and certain timelines for registration. In chapter three, detailed materials requirements for dossier preparation are explained. According to it, the following information must be prepared: 

1. Name, address, and contact information of the filing person.
2. Name, address, and contact information of the production enterprise.
3. Product name information. 
4. Product formula.
5. Product execution standards.
6. Product label sample. 
7. Product inspection report.
8. Product safety assessment information. 

The three annexes are Standard Preparation Instructions for Toothpaste Product Implementation, Toothpaste Product Implementation Standards (sample) and Requirements for Microbiological and Physical and Chemical Inspection Items for Toothpaste Registration.

The Management Rules will be enforced the same time as the Supervision and Management Measures of Toothpaste Products on 1st Dec. 2023. For more information, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com.