China toothpaste filing - Deadline to complete is November 30, 2023
China has launched a simplified toothpaste notification route for any toothpaste currently sold in China. The deadline to complete the simplified filing is November 30, 2023.
So if you currently sell toothpaste in China, please contact your local Cisema consultant or email us to take advantage of the simplified filing without delay.
The National Medical Products Administration (NMPA) only recently released its Toothpaste Simplified Filing Guidelines and opened a short time frame in which to notify the NMPA of any toothpaste currently sold in China.
Read our article here for more information about the implementation of toothpaste regulations in China or get in touch with our specialists.
So how do you submit a simplified toothpast filing in China?
Below we outline the China simplified toothpaste notification process in two simple steps.
Step 1: Appoint an NMPA Domestic Responsible Agent
As a foreign manufacturer, your first step is to nominate a local Responsible Person known as the NMPA Domestic Responsible Agent (DRA). NMPA stands for the National Medical Products Administration and is the regulatory body responsible for cosmetics and cosmetic ingredients in China. While toothpaste is not officially classed as a cosmetic in China, toothpaste is regulated under the Cosmetic Supervision & Administration Regulations (CSAR) 2021.
The NMPA Domestic Responsible Agent is responsible for product and ingredient filing and registration, supervision of tests, post-market surveillance activities including the storage of product samples, amongst other activities.
The DRA is your point of contact and representative for all interactions with the regulator (NMPA) and so they should have a wealth of experience with relevant regulatory issues and cosmetic product standards. As well as a good working history with the responsible authorities and the ability to store product samples over the long term for possible NMPA inspections.
Step 2: Filing your toothpaste product in China
The next step is to submit the toothpaste filing application.
The simplified filing procedure is new and not well documented at present however the following information should be prepared as a minimum:
- The name, address, contact information of the toothpaste manufacturer
- The basic product information, including product name, product formulation, images of the product sales package and labeling
- Documents that prove sales history in China
- Documents to prove that the product has a history of safe use, including, but not limited to, inspection reports and other relevant information.
What happens if you miss the November 30, 2023, deadline to notify toothpaste in China?
You will be required to either file or register your toothpaste from December 1, 2023. This means a timeline of 4-6 months for toothpaste requiring filing or 8-12 months for toothpaste requiring registration. And while you wait to obtain the relevant toothpaste certificates you will not be able to sell your toothpaste in China.
We strongly encourage you to start the simplified filing process ASAP to avoid any sales block in China.
