China Special-use Cosmetics License Renewal FAQs

On May 30th, 2019, China National Medical Products Administration (NMPA) released an interpretation of the new policy of special-use cosmetics license renewal ^[1]. The interpretation answers 7 FAQs on how the new policy is implemented ^[2].

Q1: What is the commitment approval system for special-use cosmetics license renewal?

A1: Applicants intending to extend the validity period of domestic/imported special-use cosmetics license must apply for renewal after conducting product self-inspection. If the product passes the self-inspection, the applicant shall submit the self-inspection commitment report and application documents to NMPA.

NMPA will not conduct the pre-market technical review. Products which passed enterprises’ self-inspection will be issued with renewed license directly. Products quality and safety can be ensured by post-market technical review and routine supervision and inspection. By definition special-use cosmetics undergoing a license renewal application have already been sold in the market for 4 years or more, have generally already undergone rigorous technical review and have been tested during post-market inspections for more than 4 years. This extensive testing and long safety record is enough to substantiate product safety etc. and likely provides the rationale for the new policy.

△Comparison between the Original and New Procedures for Special-use Cosmetics License Renewal:

Q2: What are the problems that the new policy solves?

A2:

1. Improve the efficiency of license renewal

2. Clarify enterprises’ self-inspection requirements and improve product quality and safety

3. The new policy clarifies that products cannot be imported or manufactured if the previous license expires and the applicant does not receive the renewed license.

Q3: How to arrange the time for product self-inspection and license renewal application?

A3: Applicants intending to extend the validity period of domestic/imported special-use cosmetic license must conduct product self-inspection 6 months prior to the expiry date of the license and apply for renewal 30 working days prior to the expiry date of the license.

Example:
A product’s license is valid from June 1^st, 2016 to May 31^st, 2020. Enterprises should begin product self-inspection after November 30^th, 2019. The scope of self-inspection should include product manufacture and operation conditions from June 1^st, 2016 to November 30^th, 2019. The application for license renewal shall be submitted before April 20^th, 2020.
 

Q4: Is it allowed to supplement documents during formal examination?

A4: There is no conclusion of “Supplement Documents” after formal examination. Applications with unqualified documents will not be accepted and all the documents will be returned with specific reasons to allow for rectification and resubmission. The applicant can re-apply for license renewal provided there are more than 30 working days before the expiration of the existing license.
 

Q5: How to calculate the validity period of a renewed license?

A5: The validity period for a renewed license shall be counted from the date of expiration of the previous license.

Example:
A product’s validity period is from June 1^st, 2016 to May 31^st, 2020. The renewed license’s validity period will be from June 1^st, 2020 to May 31^st, 2024.
 

Q6: What is the time limit for supplementation of documentation during post-market technical review?

A6: There is no unified time limit in which additional documentation must be provided. The time limit will be set by NMPA Cosmetics Technical Review Department according to the specific situation.
 

Q7: How will authorities deal with non-compliant products found during post-market technical review?

A7: The new policy adjusted the license renewal procedures, but did not relax the requirements for product safety. If the application documents are incomplete or need further explanation, the applicants shall submit supplementary documentation within a specific time limit. If any falsified documentation or information is provided the product license will be revoked.

△ Click here to see the details of the new policy for special-use cosmetics license renewal.