China to Simplify the Filing Documents Requirements for Marketed Toothpaste

To regulate the administration of toothpaste products and safeguard the health of consumers, China's National Medical Products Administration (NMPA) published a notice on fully implementing the requirements of toothpaste administration regulation and simplifying the documents requirements for toothpaste that has already been placed on the market.

Details are as follows:

1. Implement the requirements of toothpaste regulations and the main responsibility of the filer

According to the provisions of the Cosmetic Supervision and Administration Regulation (CSAR) and the Measures for Toothpaste Supervision and Administration (the Measures), toothpaste filers, as the responsible entity for product quality, safety, and efficacy, should be enterprises or organizations established in accordance with the law. They should have the ability to conduct quality management, adverse reaction monitoring, and evaluation of the registered products.

When the toothpaste filer first conducts product filing, they shall submit relevant materials with corresponding capabilities via the toothpaste filing information service platform (filing platform) designated by the competent authority.

2. Scientifically evaluate safety risks and simplify the requirements for filing documents of marketed toothpaste

Before CSAR and the Measures officially took effect, a certain number of toothpaste products had already been on the market for a long time. For this reason, the NMPA announced that it was necessary for marketed toothpaste products that had not encountered any quality and safety-related incidents and could fully prove their history of safe use, given that their safety had been widely verified during product use, should be distinguished from new products, thus the requirements for filing documents could be simplified.

Toothpaste filers can submit the simplified documents via the filing platform to process the filing of their products between October 1, and November 30, 2023.

Background

On March 23, 2023, NMPA officially the Measures, which will take effect from December 1, 2023.

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. Under the CSAR issued in 2020, the authorities began classifying toothpaste as ordinary cosmetics and are subject to registration or filing as per their degree of risk.

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CIRS is to host a free webinar on the new filing requirements for toothpaste in China on December 11-12, 2023. This webinar is available in English, Chinese, Japanese and Korean, clickhere to know more details.

Further Information

Official Notice

Interpretation of the Measures for Toothpaste Supervision and Administration