Last Updated on June 4, 2022 by Ithos Global Regulatory Team
The China National Medical Products Administration (NMPA) issued an Announcement of the State Food and Drug Administration on matters concerning the implementation of the “Regulations on the Administration of Cosmetics Registration and Filing Documents” (No. 35 of 2021) on March 5, 2021.
These regulations go into effect May 1, 2021. A new registration site will be implemented and the existing site will not accept new registrations as of May 1. The Provisions of Management of Cosmetics Registration and Notification provide more details.
The Provisions include 60 articles and 24 annexes including information concerning:
- User Information Requirements for first time registration of special product and notifications of cosmetic products with procedures on updating the file when information changes
- Requirements including information needed for Registrations and Notifications
- Requirement for a China based Responsible Person
- Requirements for documentation of a Quality Management System
- Requirements for GMP Certificates which are issued or recognized by the
- competent government departments, certification institutions or third parties of their country(region).
One of the troublesome issues is that not all country, regional, or local governments have such certification programs. Although China claims there are many ways to achieve this, the reality is this documentation has proven difficult to get, and China has not approved most of the alternative documentation submitted. This in turn is critical to companies who want to avoid animal testing, as this documentation is required to avoid local animal testing in China.
Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers were also issued.
These provisions go into great details concerning documentation and information requirements. There are monitoring and reporting provisions. The end result of a successful introduction of a new ingredient will be inclusion in the Inventory of Existing Cosmetics Ingredients in China (IECIC). The ingredient rules offer the real chance to have ingredients new to China enter the market.
Industry groups have just received the translation and are reviewing the changes between the first draft and the final rule and what effects it will have on procedures going forward. They have have also received information that the NMPA is said to be reexamining some provisions based on comments received based on their WTO (World Trade Organization), and may lessen some of the requirements, which was virtually impossible to accomplish since 2010 rules went into place.