On Apr. 23 and Apr. 25, 2021, China introduced transitional processing measures on the existing registration applications of NCI 1 and released Technical Guidance for Submission of Cosmetics Registration and Notification Dossiers (Trial) 2.
1. Technical Guidance for Submission of Cosmetics Registration and Notification Dossiers (Trial)
This Guidance specifies detailed requirements relating to registration and notification of cosmetics and NCI, such as obtaining the user account, opening user permission, submitting paper and electronic documents, the format of documents, etc.
Enterprises can submit the registration and notification documents by either of the following two methods:
Submitting electronic documents and a few paper documents;
Submitting all paper documents.
Method One: Electronic Documents + A Few Paper Documents
1) Submitting Electronic Documents Online
Cosmetic product and NCI registrant, notifier, domestic responsible person (hereafter referred to as RP), and cosmetic manufacturer shall first submit the electronic registration/notification documents through the Cosmetic Registration and Notification Information Service Platform (hereafter referred to as information service platform). Electronic documents shall have electronic signatures and seals.
The registrant, notifier, and RP can use the electronic signature and seal after completing the Certificate Authority (hereafter referred to as CA) application and setting. The electronic signature and seal have the same legal effect as the physical seal. The electronic documents with electronic signatures and seals are legal and valid when applying for registration and notification.
2) Submitting A Few Paper Documents
After receiving the review opinions for the electronic documents, the registrant, notifier, RP, and cosmetic manufacturer shall submit the paper documents to the registration or notification administration departments.
Required paper documents are 1) original documents 2) information forms stamped or signed by the overseas registrants or notifiers. The following table shows the paper documents that can be exempted from submission.
Paper Document Types
Resume of the person in charge of quality and safety, an overview of the quality management system, an overview of the adverse reaction monitoring and evaluation system
Can be exempted from submission
Ingredient source and safety information
Can be exempted from submission
Certification documents issued by third-party institutions
Can be exempted from submission if the certification documents have electronic signatures and seals and can be effectively obtained and verified through the information service platform
Can be exempted from submission if the documents have electronic signatures and seals
*The certification documents of good manufacturing practice of overseas manufacturers can be archived by the applicant for reference after being submitted to the registration or notification administration department for verification.
Table 1: Paper Documents that Can Be Exempted from Submission
For NCI and imported general cosmetics notification, the notifier or RP shall submit paper documents to the notification administration department before the notification information disclosure.
For special cosmetics and NCI registration, the registrant or RP shall submit paper documents to NMPA acceptance center. The acceptance center will conduct a formal review in accordance with Administrative Measures on Cosmetics Registration and Notification after receiving the electronic and paper documents.
Method Two: Submitting All Paper Documents
1) Filling in the information of All Documents
Applicants without electronic signature or seal shall first fill in the information of all the registration/notification documents through the information service platform.
2) Uploading Scanned Copies of Paper Documents
Print, stamp, and scan the registration/notification documents, and upload the scanned copies to the information service platform.
3) Submitting Paper Documents
Submit all the paper documents to the registration or notification administration department, and attach a statement stating that the paper documents are consistent with the content filled in the information service platform.
For detailed submission requirements for registration and notification documents, please contact email@example.com for English translation service.
2. Transitional Measures on the Existing NCI Applications
1) NCI applicants can apply for withdrawing the existing registration applications by either of the following two methods before May 1, 2021.
Get the original documents from the NMPA acceptance center by submitting the stamped acceptance notice, a power of attorney (stamped with the applicant's official seal), and a copy of the applicant's identity card;
Mail the stamped acceptance notice and the return statement (stamped with the applicant’s official seal) to the acceptance center. After receiving the documents, National Institutes for Food and Drug Control (hereafter referred to as NIFDC) will return the original application documents according to the address and contact information on the return statement.
2) If NCI applicants fail to apply for withdrawing the registration applications before May 1, 2021, NIFDC will continue to complete the document review in accordance with Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers.
Hesheng Chi, director of Robertet Group, believes the existing NCI registration applications submitted in accordance with the old regulations will not be approved, because the document requirements have been updated under the new regulations. He suggests, “During the transitional period, enterprises should first withdraw the existing registration applications and update documents in accordance with the new regulations, then apply for NCI registration and notification.” 3
ChemLinked will hold a webinar on Apr. 28 to share the latest information about the updated cosmetic registration and notification regulations after participating in the internal training organized by China NMPA. FAQs such as “What kind of good manufacturing practice certificate is recognized for exempting animal testing? Does NMPA accept foreign efficacy evaluation reports? How to manage NCI whose usage exceeds the historical highest usage?” will be answered. Registration for the webinar is welcomed.