China Introduces Transitional Processing Measures on Existing Applications of 5 Types of Products

In response to NMPA's transitional measures on 5 types of special cosmetics, namely hair growth products, depilating products, breast beauty products, slimming products and deodorants, China National Institute for Food and Drug Control (NIFDC) introduced transitional processing measures on the existing registration applications of the 5 types of products based on different situations.

Situation 1: Depilating products, breast beauty products, slimming products and deodorants

NIFDC listed 170 products with applications accepted but no registration decision made yet. Corresponding applicants are required to apply for the return of application dossiers by either of the following two methods before Mar 31, 2021:

1. Receive the original application dossiers from the NMPA acceptance center by submitting the stamped acceptance notice, the power of attorney (stamped with the applicant's official seal) and a copy of the applicant's identity card.

2. Mail the stamped acceptance notice and the return statement (stamped with the applicant's official seal) to the acceptance center. After receiving the documents, the NIFDC will return the application dossiers based on the address and contact information on the return statement.

The original application dossiers that are not collected within the prescribed time limit will be filed by the NIFDC and transferred to the NMPA.

Situation 2: Hair growth products

NIFDC listed 133 products with applications accepted but no registration decision made yet. For those products, the NIFDC will issue a review opinion of "please confirm the product category, if it belongs to anti-hair loss cosmetics, please adjust and supplement relevant documents in accordance with current regulations." Applicants may follow the following processing ways:

1. If the product is an anti-hair loss cosmetic according to the Cosmetic Supervision and Administration Regulation (CSAR), the applicant shall adjust and supplement relevant documents in accordance with current regulations. The registration application will continue to be reviewed and approved.

2. If the product is a cosmetic but not an anti-hair loss cosmetic according to the CSAR, the applicant can apply for the notification of general cosmetics later. The product testing reports, safety assessment documents and related supporting documents in the original registration dossiers can be submitted as notification documents. Since related original documents have been submitted as parts of registration dossiers and cannot be obtained, applicants can submit their copies with applicants' stamps and relevant explanations for notification. 

If applicants fail to supplement required documents within the prescribed time limit, the applications will be disapproved, and related dossiers will be filed by the NIFDC and transferred to the NMPA.

Situation 3: Re-issuance, correction and modification of registration licenses for the 5 types of products

The applications for re-issuance, correction and modification of registration licenses for the 5 types of products will continue to be reviewed and approved. For other licensing matters, they will not be accepted.

It should be noted that the above-mentioned modification is only limited to:

1. Change the names of the production company or actual production company

2. Change the description of the production company address or actual production company address (the actual production company address is not changed)

3. Change the domestic responsible person