NMPA's Opinions on Cosmetics Supervision Reform and Industry Development (Draft)

Cosmetics are important consumer goods that meet the people's demand for beauty and their yearning for a high-quality life. In recent years, drug supervision authorities have actively advanced the reform of cosmetics supervision, accelerated the improvement of the legal system for cosmetics supervision, refined regulatory systems and mechanisms, and innovated supervision methods. As a result, China's cosmetics industry has achieved vigorous development, and the level of quality and safety has been continuously enhanced. To further balance the high-quality development and high-level safety of cosmetics and better meet the people's new aspirations for a better life in the new era, the following opinions are put forward on deepening the reform of cosmetics supervision and promoting the high-quality development of the cosmetics industry.

I. General Requirements

Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, we will fully implement the spirits of the 20th National Congress of the Communist Party of China (CPC) and the Second and Third Plenary Sessions of the 20th CPC Central Committee, and fulfill the requirements of comprehensively deepening reform. Based on the new development stage, we will apply the new development concepts and build a new development pattern. We will adhere to the scientific, law-based, internationalized and modernized path of supervision and development, and in accordance with the requirements of "upholding political integrity, strengthening supervision, ensuring safety, promoting development and benefiting the people", we will focus on balancing development and safety, vitality and order, quality and efficiency, as well as supervision and services. We will further enhance the systematicness, integrity and coordination of supervision reform, deepen the reform of cosmetics supervision throughout the whole process, consolidate the bottom line of cosmetics safety in all aspects, and support the high-quality development of the cosmetics industry across the entire industrial chain. We will accelerate China's leap from a "large cosmetics-producing country" to a "powerful cosmetics-producing country", and effectively enhance the people's sense of gain, happiness and security in the field of cosmetics.

By 2030, the legal system for cosmetics supervision will be more improved, the standard system will be more sound, the technical support will be more powerful, the innovation vitality of the industry will be more abundant, the risk prevention and control capabilities will be comprehensively strengthened, and the level of quality and safety will be significantly enhanced. By 2035, China's cosmetics quality and safety supervision system will reach an internationally advanced level. The supervision system, supervision mechanisms and supervision methods will be better adapted to the inherent requirements of industrial innovation and high-quality development. The industry will have stronger innovation capabilities and global competitiveness, and the modernization of supervision will be basically realized.

II. Strengthening Support for the Innovation of the Cosmetics Industry

(1) Smooth the Registration Channels for Cosmetics with New Efficacy

To adapt to the new consumer demands of society, we will study and establish a pre-application consultation mechanism for the registration of cosmetics with new efficacy. We will review applications for cosmetics with new efficacy as soon as they are received, promptly determine the category of such cosmetics, dynamically adjust the classification rules and catalogs for cosmetics, and support the registration and application of cosmetics with new efficacy.

(2) Encourage the First Launch of New Cosmetic Products in China

Aligning with high-standard international economic and trade rules, we will foster the first-launch economy in China's cosmetics field. For international new cosmetic products with outstanding innovation leadership that are first launched in China or simultaneously launched in China and other countries (regions), if they meet the requirements for cosmetics registration and filing materials in China, they shall be regarded as cosmetics produced exclusively for export to China, and shall be exempted from submitting documents proving their marketing in the country (region) of production.

(3) Promote the Development of the Silver Economy in the Cosmetics Sector

We will encourage enterprises to strengthen the technological research and development of cosmetics for the "silver generation" and conduct cutting-edge basic research on mechanisms such as skin aging. We will support the development, application, registration and filing of cosmetics that are suitable for the characteristics and needs of the elderly group, so as to meet the diversified consumption demands of the elderly.

(4) Innovate the Management of Cosmetic Labels

To adapt to the needs of the intelligent and green development of the cosmetics industry, we will accelerate the implementation of electronic labels for cosmetics, formulate requirements for the marking and data management of cosmetic electronic labels, and realize the digital upgrading and refined governance of label management.

(5) Innovate Personalized Service Models

To meet the public's demand for personalized and precise consumption, we will adhere to the principles of demand orientation, safety control, and standardized order, explore paths for personalized cosmetic services, and allow cosmetic filers to provide on-site services such as simple preparation and repackaging of filed ordinary cosmetics at their business premises according to consumers' needs.

(6) Strengthen Industrial Support

We will encourage provincial drug supervision authorities to actively seek government support, coordinate with relevant departments to issue policies supporting the cosmetics industry, create a favorable environment for industrial innovation, promote the rise of brands through policy empowerment, and cultivate national brand cosmetics with international competitiveness.

III. Enhancing the Efficiency of Cosmetics Registration and Filing Management

(7) Support the Technological Innovation of Cosmetic Raw Materials

We will improve the classified management and technical evaluation system for new raw materials, explore the establishment of raw material naming rules that are in line with national conditions and international standards, and formulate technical standards for raw materials that are widely used in the industry, have high safety risks, and are Chinese characteristic plant resource raw materials. We will build a collaborative mechanism for R&D and review, establish a pre-application consultation channel for eligible new raw materials, and provide full-process services including early intervention, process guidance and dynamic optimization.

(8) Optimize Cosmetics Registration and Filing Materials

On the premise of ensuring the quality and safety of cosmetics and meeting supervision needs, cosmetics of the same brand with similar formula systems are allowed to share safety technical materials during registration and filing. We will strengthen the main responsibility of cosmetic registrants/filers for quality and safety, and adjust the information related to the safety of cosmetic raw materials to be archived and kept by enterprises themselves for inspection.

(9) Improve the Quality and Efficiency of Technical Review

We will explore the establishment of a joint review and collaboration mechanism between the "National Medical Products Administration and provincial drug supervision authorities", and entrust provincial drug supervision authorities with the capability to undertake part of the technical review work for special cosmetics. We will implement classified management for changes to special cosmetics, and shorten the review time for high-risk and low-risk changes from 90 working days to 60 working days and 45 working days respectively.

(10) Optimize the Safety Assessment System

We will strengthen the research and innovation of cosmetic safety assessment technologies, promote the application of advanced assessment technologies and strategies, continuously improve the technical guidelines for cosmetic safety assessment, and enhance the scientificity and accuracy of assessment work. We will guide and urge cosmetic enterprises to strengthen the concept of safety assessment, fulfill their responsibilities for the whole-life cycle management of products, and continuously improve their ability to ensure product quality and safety.

(11) Optimize the Management of Efficacy Claims

Cosmetic registrants/filers are allowed to independently select efficacy claim evaluation test methods to conduct efficacy claim evaluation for ordinary cosmetics. Products of the same brand with similar formula systems that only differ in the type or content of ingredients such as colorants, fragrances and preservatives are allowed to share the efficacy claim evaluation test data. We will support social organizations such as cosmetics industry associations to strengthen self-discipline, focus on key efficacy categories of general concern to the industry, study guidelines for cosmetic efficacy claims, and guide the standardization of label claim terms.

IV. Improving the Supervision Mechanism for Cosmetics Production and Operation

(12) Promote Classified and Categorized Supervision of Enterprises

We will encourage drug supervision authorities at all levels to establish and improve a classified and categorized management mechanism for cosmetic production and operation entities in accordance with the principle of risk management. Based on key factors such as enterprises' quality management systems and risk prevention and control capabilities, we will scientifically assess risk levels, rationally allocate supervision resources, and effectively improve supervision efficiency.

(13) Optimize Production Quality Management

We will further carry out initiatives to improve the production quality management system of cosmetic enterprises, continuously deepen and improve the quality and safety responsible person system, and comprehensively enhance the operational efficiency of enterprises' production quality management systems and their ability to ensure product quality and safety. We will encourage provincial drug supervision authorities to promote the establishment of a professional title evaluation system for quality and safety professionals in cosmetic R&D and production, testing and analysis, and safety and efficacy evaluation. We will also encourage provincial drug supervision authorities to explore quality management requirements adapted to the intelligent production of cosmetics and product release management requirements for external warehouses that implement the same production quality management system as the production site.

(14) Strengthen Supervision of Online Operations

We will improve the supervision mechanism of "regulating the internet through the internet", continuously optimize the functions of the National Cosmetics Online Operation Monitoring Platform, and improve the ability of risk identification and online monitoring efficiency. We will strengthen the management responsibility of e-commerce platforms for operators on the platform, continuously enhance the supervision collaboration and risk co-governance mechanism, promote the joint efforts of administrative supervision and platform governance, and identify and resolve potential safety risks of cosmetics. We will strengthen key monitoring of typical illegal acts such as unregistered/unfiled products, illegal addition of prohibited substances, and self-preparation by operators, so as to improve the quality and safety level of cosmetics sold online.

(15) Strengthen the Monitoring and Evaluation of Adverse Reactions

We will improve the cosmetic adverse reaction monitoring system, optimize and upgrade the functions of the adverse reaction monitoring platform, improve the adverse reaction information reporting mechanism, strengthen data quality management, and enhance the accuracy and availability of monitoring data. We will promote the sharing of national adverse reaction monitoring data, fulfill the main responsibility of cosmetic registrants/filers for analysis and evaluation, further strengthen the in-depth analysis, scientific evaluation and risk assessment of monitoring data, and promote the transformation and application of evaluation results.

(16) Strengthen Extended Supervision of Registration and Filing

We will promote provincial drug supervision authorities to strengthen the verification of the authenticity of registration and filing data in accordance with the needs of cosmetics registration and filing work, explore the conduct of extended inspections of inspection institutions, and promote the construction of a whole-chain risk prevention and control system.

V. Strengthening Technical Support for Cosmetics Supervision

(17) Strengthen the Capacity Building of Supervision Teams

We will augment the professional and technical personnel for cosmetic review, optimize the structure of the cosmetic inspector team, and strengthen the systematic training, professional management and scientific assessment of the cosmetic review and inspector teams. We will encourage provincial drug supervision authorities to deepen exchanges and cooperation, strengthen resource sharing, information communication and supervision coordination, and actively explore innovations in supervision models. We will also encourage provincial drug supervision authorities to actively participate in the registration of special cosmetics and pre-application consultation for the registration and filing of new cosmetic raw materials.

(18) Improve the Construction of the Standard System

We will accelerate the development of a scientific, unified, authoritative and efficient cosmetics standard management system, and study and formulate a plan for the development of cosmetics standards. We will accelerate the development of mandatory national standards centered on safety assurance and strengthen the binding force of basic safety standards. We will focus on key areas and weak links such as raw material safety control, safety and efficacy evaluation, and the application of emerging technologies, and accurately fill the gaps in the standard system to provide standardized support for the standardized development of the industry and the improvement of quality and safety.

(19) Deepen Regulatory Science Research

We will give full play to the role of innovative research bases for cosmetic regulatory science, and arrange major scientific research tasks focusing on key areas such as safety assessment, innovative products and raw materials, and risk early warning. We will improve the mechanism for the transformation and application of regulatory science research results, accelerate the research and development of new regulatory tools, standards and methods, and enhance the scientificity and modernization level of supervision.

(20) Strengthen the Construction of Supervision Informatization

We will continue to advance the construction of the National Cosmetics Smart Supervision Platform, improve the database of "one file per enterprise" for cosmetic registrants/filers, and further exert the role of file data in supervision. We will upgrade and optimize the functions of the Cosmetics Supervision APP to improve the efficiency of grass-roots supervision services and the level of public science popularization services. We will encourage provincial drug supervision authorities to accelerate the intelligent transformation, strengthen the application research of artificial intelligence in the supervision of cosmetic filing, production and operation, and improve the efficiency of supervision work.

VI. Promoting the Alignment of Cosmetics Supervision with International Standards

(21) Deepen International Exchanges and Cooperation

We will deeply participate in the formulation of technical documents and supervision coordination under the framework of international cosmetics supervision cooperation organizations, and establish and improve a normalized tracking, research and response mechanism for international cosmetics supervision trends. We will actively promote the convergence, coordination and mutual recognition of cosmetics supervision, encourage social organizations such as cosmetics industry associations to serve the "going global" of domestic cosmetics, and help the international development of China's cosmetics industry.

(22) Enhance the Internationalization Level of Standards

We will deepen the research on the international cosmetics standard system, accelerate the transformation and application of internationally accepted standards, and promote the alignment of domestic standards with international standards. We will actively participate in and promote the project approval, research and formulation of international standards, and enhance China's influence and voice in the field of international cosmetics standards.

(23) Accelerate the Reduction and Replacement of Animal Testing

Following the principles of "reduction, replacement and refinement", we will accelerate the reduction of reliance on animal testing for cosmetics, starting with low-risk products such as perming products and non-oxidative hair dyes, and gradually promote the exemption of animal testing. Adhering to the principle of "replacing as much as possible", we will accelerate the development and transformation of alternative animal testing methods and expand the application scope of alternative animal testing.

(24) Optimize the Management Mechanism for Allowed Raw Materials

We will establish a dynamic update mechanism for standards for preservatives, sunscreens, colorants, hair dyes, etc., and support the inclusion of raw materials that have been scientifically evaluated by international authoritative institutions and have a history of safe use abroad into China's list of allowed raw materials through standard revision.

Drug supervision authorities at all levels shall integrate the adherence to and strengthening of Party leadership into all aspects and the whole process of deepening the reform of cosmetics supervision. They shall deeply understand the great significance of deepening the reform of cosmetics supervision for promoting the high-quality development of the industry, firmly implement the "four strictest" requirements (the strictest standards, strictest supervision, strictest penalties and strictest accountability), and with a high sense of responsibility and mission, fully implement all the reform measures and work requirements put forward in these Opinions in light of the actual situation of their respective regions, so as to ensure that all reform tasks are implemented in place and achieve results.

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