Guidelines for the Information Submission of Cosmetics Registration and Filing (Trial Version)

In accordance with the CSAR (Cosmetics Supervision and Administration Regulation), the NMPA (National Medical Products Administration) released the Technical Guidelines for the Submission of Information for Cosmetics Registration and Filing (Trial Version) on April 25, 2021.

Highlights

• The regulatory draft applies to the registration and filing process of both cosmetics and new ingredients, e.g., user account activation and data submission.
• Once the Domestic Responsible Agent (DRA) has obtained the digital certificate (Certificate Authority, CA), the submission of the paper version can be replaced by the digital version to the NMPA. The changes before and after the implementation of this trial version is listed below:
  • Before the implementation
    • The digital certificate (Certificate Authority, CA) didn’t exist.
    • The NMPA accepts the original hard copy of the required documents (registrant/filer application form, adverse reaction monitoring overview form, quality management system overview form, etc.) that must be signed and stamped for submission.
  • After the implementation
    • The digital certificate (Certificate Authority, CA) was introduced in the technical guidelines for this trial version.
    • The NMPA accepts the original hard copy or electronic version of the required documents (registrant/filer application form, adverse reaction monitoring overview form, quality management system overview form, etc.) that still must be signed and stamped for submission. However, the DRA needs to obtain the CA to meet the precondition for submitting the electronic version.

By James Xu. Contact Cisema if you would like to learn more.