From December 20 to 21, EnterCo attended the toothpaste notification training organized by the National Medical Products Administration Institute of Executive Development (NMPAIED), and systematically studied the main content in the Measures for the Supervision and Management of Toothpastes, and the Provisions for Notification Dossiers of Toothpastes, toothpaste notification common problems, toothpaste notification inspection, efficacy evaluation requirements, toothpaste filer requirements, etc. Now we share the key contents of the training with you:
General Requirements for Toothpaste Notification
What are the permitted efficacy claims for toothpaste?
From an efficacy point of view, toothpastes can be categorized into the following two groups:
General toothpaste: cleansing efficacy only, including cleaning the mouth, reducing soft tartar, maintaining oral hygiene, and freshening breath.
Functional toothpaste: toothpaste with efficacy ingredients added to general toothpaste.
According to the QB/T 2966-2014 Functional toothpastes, the efficacy of functional toothpaste are as follows: cleansing, anti-caries, plaque inhibition, anti-dentin sensitivity, gum problem reduction, whitening, anti-tartar, bad breath reduction, and other effects.
The efficacy in the current toothpaste classification code contains only five major categories: cleansing, anti-caries, plaque inhibition, anti-dentin sensitivity, and gum problem reduction.
Do toothpaste products that have completed the simplified filing need to be removed from sale for recall if the original packaging for marketed toothpaste products is non-compliant?
Currently, there are no apparent regulatory requirements for this situation. If there are obvious non-compliant claims (especially involving medical terminology), it is recommended that the enterprise recall them.
Toothpaste Notification Management
Where to submit notification information for imported toothpaste?
Imported toothpaste should be notified to the National Medical Products Administration before importation.(https://hzpba.nmpa.gov.cn/)
How do overseas enterprises apply for toothpaste notification?
Overseas enterprises need to appoint a domestic responsible person (it should be an Enterprise Legal Person, not a natural person, university, or dental hospital, etc.), who is responsible for filing and assisting in monitoring adverse reactions of toothpaste, implementing product recalls, and cooperating with the supervision and inspection work of the drug regulatory department.
What are the differences in the notification materials between domestic toothpaste and imported toothpaste?
Imported toothpaste requires additional proof documents that they have been marketed and sold overseas. If imported toothpaste is specifically designed for the Chinese market and has not yet been marketed, additional research materials targeting Chinese consumers are needed.
If imported toothpaste involves an overseas factory that is unable to provide a production license from China, it is required to provide proof documents that comply with the quality management standards for cosmetics production, such as a GMP certificate.
Is Little Golden Shield suitable for children's toothpaste?
Yes, toothpaste products claiming to be suitable for children, or suitable for the whole family, etc., implying that they are suitable for children, need to be regulated by the Children's Toothpaste and Cosmetics Standard, and should be labeled with the Little Golden Shield on the product label. Note that the "Children's Cosmetic" in the Little Golden Shield logo should be changed to "Children's Toothpaste".
What claims can be made for children's toothpaste?
In addition to the cleansing function, only anti-caries can be claimed.
Toothpaste Notification Inspection
Can foreign inspection reports be used for product filing?
1) Microbial, physicochemical, and toxicological tests: Overseas reports are not accepted. It needs to be completed by domestic registered inspection institutions or enterprises with self-inspection capabilities.
2) Efficacy evaluation: It is acceptable for overseas institutions that meet GCP qualifications to conduct.
What toothpaste efficacy is subject to human efficacy evaluation tests?
Toothpaste claiming to have the efficacy of anti-caries, plaque inhibition, anti-dentin sensitivity, and gum problem reduction are subject to human efficacy evaluation.
Do I have to conduct the human efficacy evaluation test of toothpaste in a hospital?
The human efficacy evaluation test of toothpaste needs to be conducted in an institution with GCP qualification.
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