China NMPA Implements the Finalized Good Manufacturing Practices for Cosmetics
In September 2020 and 2021, China National Medical Products Administration (NMPA) released the first and the second draft of Good Manufacturing Practices for Cosmetics (hereinafter referred to as “Practices”). After two rounds of public consultation, on January 7, 2022, NMPA released the finalized Practices and implemented it on July 1, 2022. 1
- Starting from July 1, 2022, cosmetics registrants, notifiers, and entrusted production enterprises (including cosmetic enterprises that only engage in the preparation of semi-finished products, and toothpaste enterprises) shall organize the cosmetic production in accordance with the Practices;
- For enterprises that have obtained production licenses before July 1, 2022, if their facilities, equipment, etc., shall be upgraded according to the Practices, the upgrading and reconstruction shall be completed before July 1, 2023.
Main Contents
The Practices are divided into nine chapters with two annexes, covering all aspects of cosmetic production and quality control such as ingredients, personnel, equipment, sanitation, inspection, packaging, storage, transportation, sales and recall. The promulgation of the Practices indicates that cosmetics production in China enters a more standardized era.
| Chapter I General Rules
Chapter II Institutions and Personnel Chapter III Quality Assurance and Control Chapter IV Plant Facilities and Equipment Management Chapter V Materials and Products Management Chapter VI Production Management Chapter VII Entrusted Production Management Chapter VIII Product Sales Management Chapter IX Supplementary Rules Annex I Electronic Record Requirements for Cosmetics Production Annex II Environmental Requirements for Cosmetics Production Plant |
Key Points
Based on the quality control requirements in Practice for Cosmetics Production Licensing issued in 2015, the Practices\’ formulation supplements and refines relevant contents combined with the problems found in regulatory and supervisory practice. The three key points of the Practices are as follows:
1. Finalizes the qualification requirements and duties of the person in charge of quality and safety
Cosmetic registrants, notifiers and entrusted product enterprises (hereinafter collectively referred to as the \”enterprises\”) shall set up a person in charge of quality and safety to establish a production quality management system, put the product on the market, and be responsible for the product\’s quality, safety, and efficacy claims. The person in charge of quality and safety shall perform their duties independently without interference from other personnel from the enterprise, and shall not concurrently serve as the person in charge of the production department.
| Qualification Requirements for the Person in Charge of Quality and Safety | Duties of the Person in Charge of Quality and Safety |
| 1) Having cosmetics, chemistry, chemical engineering, biology, medical science, pharmacy, food, public health, legal science or other cosmetic quality and safety professional knowledge;
2) Being familiar with relevant laws, regulations, rules, mandatory national standards, and technical norms; 3) Having more than five years of experience in cosmetic production or quality management. |
1) Establishing and organizing the enterprise’s production quality management system, fulfilling quality and safety management responsibilities, and regularly reporting the operation of the quality management system to the legal representative;
2) Making decisions on product quality and safety issues and issuing relevant documents; 3) Reviewing product safety assessment report, formulas, production techniques, material suppliers, product labels, and registration and notification documents; 4) Managing material release and product release; 5) Managing cosmetics adverse reactions monitoring. |
The Practices also points out that, with the written consent of the legal representative, the person in charge of quality and safety is allowed to designate other personnel from the enterprise to assist in performing the duties of 3), 4), and 5) in the above table. However, the legal responsibility of the person in charge of quality and safety will not be transferred to the designated person. This means that once a product safety problem occurs, the first responsible person is still the person in charge of quality and safety.
The previous draft of Practices had qualification requirements for the person in charge of quality and safety in three aspects: education, professionalism, and work experience. Therefore, scarce people were able to meet the requirements. The finalized Practices removes the requirement for educational background. In addition, NMPA allowed the group company to appoint the same person in charge of quality and safety for different subsidiaries 2, and recognized experience in drug, medical device, special food production or quality and safety management 3, which can alleviate the talent pressure faced by the industry to a certain extent.
2. Ensures the traceability of products from production to market and refine the requirements for sample retention
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