In November 2020, the National Medical Products Administration (NMPA) issued the draft of Toothpaste Supervision and Administration Measures to collect public comments. After two years of preparation, the State Administration for Market Regulation (SAMR) finally released the Measures for Toothpaste Supervision and Administration (hereinafter referred to as the “Measures”) on March 16, 2023. The Measures will be implemented from December 1, 2023.
There are 25 articles in the Measures. CIRS Group will interpret the Measures from the following aspects:
- Official responsibilities and direction of industry; and
- Requirements for toothpaste filing, raw materials, efficacy claims, and labeling;
The Measures define toothpaste as a paste-like product that is applied to the surface of human teeth by friction, with the primary purpose of cleaning. Thus, products such as tooth powder and mouthwash will no longer be applicable to these “Measures”.
Clarifies official responsibilities and industry direction
The Measures clarify the responsibilities of regulatory authorities and the direction of industry associations. The Measures specify that the NMPA is responsible for the national supervision and management of toothpaste while the municipal medical products supervision departments are responsible for the application of toothpaste production licenses and the management of imported toothpaste filing. Although the qualification requirements for efficacy evaluation institutions were not mentioned in the Measures, we believe that they will be clearly reflected in future efficacy requirements documents.
Requirements for toothpaste filing
The Measures emphasize that overseas toothpaste registrants should designate a domestic enterprise to serve as the domestic responsible person for filing. Before the filing of toothpaste, the filer must conduct safety assessments on their own or entrust professional institutions to do it on their behalf. At the same time, there are also mandatory requirements for personnel engaged in safety assessments.
Toothpaste filers should be responsible for the safety of the toothpaste ingredients they use. When filing, they should clarify the source of ingredients and information related to ingredient safety through the filing information service platform. The Measures propose submitting free sales certification documents, as well as quality management standards certification materials of overseas production enterprises or other relevant certification materials for the filing of imported toothpaste.
Requirements for toothpaste ingredients
According to the measures, new toothpaste ingredients must comply with the regulations on new cosmetics ingredients. New toothpaste ingredients with functions such as anti-corrosion and coloring can only be used after they are registered with the NMPA; other new toothpaste ingredients are subject to filing. New toothpaste ingredients that have completed registration/filing are also subject to a three-year safety monitoring period. New toothpaste ingredients that have not experienced any safety issues during the safety monitoring period will be included in the list of existing toothpaste ingredients.
Requirements for a toothpaste efficacy claim
The Measures mention that the efficacy claims for toothpaste focus on regulatory compliance and the evidence to support the claim.
Requirements for toothpaste labeling
Labeling requirements are also included in the Measures. The Measures have given specific rules on the contents that should be labeled, the naming rules, as well as the labeling of toothpaste products claimed to be suitable for children in accordance with the regulations of the NMPA.
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