China Lays down Practical Guidelines on Special Cosmetics Registration Certificate Renewal

On January 6, 2022, China National Institutes for Food and Drug Control (NIFDC) released an announcement to specify the application requirements and acceptance conditions for special cosmetic registration certificate renewal, and introduce specific policy pertaining to potential force majeure.

On December 17, 2021, China National Medical Products Administration (NMPA) announced the implementation of transitional measures for supervising the previous special use cosmetics, in which NMPA indicated the policy of renewing the special cosmetic registration certificate. On January 6, 2022, China NIFDC released the Review Points for the Acceptance of Special Cosmetic Registration Renewal Application (Trial) to roll out the detailed action plan for the renewal policy, which came into force upon its release. ¹

1. Application Requirements

Applicants intending to extend the validity of special cosmetics registration certificate shall firstly conduct a product self-inspection six months before the certificate expires, and then submit the required documents within 30-90 working days before the certificate expires if the product passes the self-inspection. The application shall be made on the information service platform for the registration and notification of cosmetics, and the required documents are:

Application form

Copy of original registration certificate

Product self-inspection report:

a. Production (import) sales certification materials

b. Administration sampling inspection, investigation and recall

c. Statistical analysis of adverse reactions of this product and measures taken

d. Other contents to be explained

Product testing report

Product executive standards or product technical requirements

2. Acceptance Conditions

After receiving the application documents, the NMPA administrative matters acceptance department will conduct a format review and then make a decision on whether to accept the application.

Review Conclusion	Conditions
Accepted	Submitted documents are complete and in line with the format review standards
Rejected	The renewal application is beyond the scope of acceptance The renewal application is not made within the prescribed time limit The application documents are incomplete The application documents are not in line with the prescribed form Mandatory national standards or technical specifications have been amended while the cosmetics applying for registration certificate renewal fail to meet the latest standards or specifications The application subject is still engaged in an application for any change or correction about the original certificate Other noncompliance circumstances exist

If the renewal application is rejected because the application subject is still engaged in an application for any change or correction about the original certificate, the registrant or domestic responsible person (RP) shall reapply within 10 working days after the completion of the engaged application. The reapplication documents include the rejection letter received for previous application and a statement of the situation. It should be noted that the application will no longer be accepted if the application is made beyond the prescribed time limit or in noncompliance with the provisions.

3. Specific Policy Pertaining to Force Majeure

If the registrant or RP fails to submit the required application documents within the prescribed time limit due to force majeure, for reasons including but not limited to natural disasters, government actions, unexpected social events or information system failures, he/she is allowed to reapply for renewal after the impact is eliminated.

The required additional documents for reapplication include:

Statement of the situation and corresponding evidence
Stamped written opinion issued by provincial MPA

Further Reading

News | China Further Clarifies Transitional Measures on the Previous Special Use Cosmetics and Cosmetics Containing Newly Prohibited Ingredients