China NIFDC Clarifies the Management Measures for the Previously Approved Imported Non-Special Use Cosmetics

Background

The import of non-special use cosmetics in China was initially subject to a registration system, requiring companies to obtain an administrative license from the former cosmetic competent authority China Food and Drug Administration (CFDA, now National Medical Products Administration (NMPA)). In 2017, China piloted the program of adjusting the registration management of non-special use cosmetics imported for the first time to filing management in Shanghai Pudong New Area, and rolled it out nationwide on November 10, 2018. Since then, the registration of imported non-special use cosmetics has been entirely replaced by filing.

On January 1, 2021, with the entry into force of China’s new overarching cosmetic regulation—Cosmetic Supervision and Administration Regulation (CSAR), general cosmetics are now subject to the new notification system, which differs from the previous “filing system” mainly in the following aspects:

	Previous Filing Management	New Notification Management
Applicable Category	Non-special use cosmetics, referring to products except for nine categories of special use cosmetics, namely, hair growth, hair dyeing, hair perming, depilating, slimming, breast beautifying, deodorant, freckle-removing, and sun-screening products.	General cosmetics, referring to all products matching the definition of cosmetics within CSAR, except for 6 types of special cosmetics (hair dyeing, hair perming, freckle-removing and whitening, sun-screening, and anti-hair loss products, as well as cosmetics claiming new efficacy).
Completion Time	The dossiers for filing shall be submitted through the platform before product launch. Filing will be completed within five working days after the format review.	Notification is completed upon the dossiers submission through the new platform.
Technical Review Period	The technical review will be conducted within three months after filing.	The technical review is conducted randomly without a fixed deadline. The stringency of technical review may be stratified based on the quantitative grading results.

NIFDC’s Notice

On June 6, 2022, China National Institutes for Food and Drug Control (NIFDC) issued a notice clarifying the registration and notification management of the previously imported non-special use cosmetics that have obtained administrative licenses through the original registration and filing platform. ¹

1. Documents Supplementation

Prior to the expiration of the product's administrative license, the Chinese responsible agent (RA) or the Chinese domestic responsible person (RP) of the original administrative license can submit the paper version of the required documents to the acceptance department of the NMPA per the  requirements for documents supplementation. After the acceptance department conducts a format review of the documents, a receipt will be issued.

2. Follow-Up Notification

Following the new regulations, the domestic responsible person for imported general cosmetics can submit relevant notification documents through the new notification platform to re-notify the previously imported non-special use cosmetics that have obtained administrative licenses. If the technical data such as product testing reports and product safety assessment data in the previous application documents for administrative licenses meet the requirements of the new regulations, they can continue to be used as notification documents at the time of re-notification.

When applying for re-notification, if the validity period of the product’s administrative license has not expired, the original filing certificate and the Application for Cancellation of the Administrative License for the Original Imported Non-Special Use Cosmetics signed and stamped by the RP shall be submitted. If the domestic responsible person and the original RA are different enterprise legal person, the informed consent form signed by the original RA should also be submitted at the same time. After the product notification is completed, the original administrative license will be automatically cancelled.

Industry Comments ²

1. This notice mainly targets the products obtained the notification certificate before the registration of imported non-special use cosmetics changing to filing management. As the cosmetic administrative license is valid for four years, such products are now due to expire.

2. NIFDC currently provides the following two ways for stakeholders to continue supplying their products:

• To supplement the paper documents to the acceptance department of NMPA;

• To re-notify on the new system with the original technical data. Notably, it is necessary to upload the “Application for Cancellation” among the submitted documents and cancel the original filing certificate.

  Industry experts suggest that companies can prioritize the second way, as the first method only allows imports within the remaining validity period of the certificate.