[2025] No.18

To all provincial-level medical products administrations (including those of autonomous regions and municipalities directly under the central government, and Xinjiang Production and Construction Corps):

Cosmetics are important consumer products that meet people's demand for beauty and their aspiration for a high-quality life. In recent years, the drug regulatory authorities have actively promoted reforms in cosmetics regulation, accelerated the improvement of the cosmetics regulatory framework, strengthened the regulatory mechanisms, and innovated regulation approaches. As a result, China's cosmetics industry has experienced robust growth, and the quality and safety levels have continued to rise. To further coordinate high-quality development and high-level safety in the cosmetics sector, and thereby better meet the people's new expectations for a better life in the new era, the following opinions are proposed to deepen the reform of cosmetics regulation and promote 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, the Opinions fully implement the spirit of the 20th National Congress of the Communist Party of China and the 2nd, 3rd, and 4th Plenary Sessions of the 20th Central Committee, and fulfill the requirements for comprehensively deepening reform. Based on the new development stage and the implementation of the new development concept, the Opinions build a new development pattern, adhering to the path of scientific, legal, international, and modern regulatory development. In accordance with the requirements of "Stressing Political Awareness, Enhancing Supervision, Ensuring Safety, Promoting Development and Improving People's Well-Being", the Opinions focus on coordinating development with safety, vitality with order, quality with efficiency, and regulation with service. The purpose is to enhance the systematic, holistic and coordinated nature of regulation reform; deepen cosmetics regulation reform across the entire process; strengthen the safety foundation of cosmetics in an all-round manner; support high-quality development of the cosmetics industry across the full-chain; accelerate China's transformation from a major cosmetics producer to a leading cosmetics powerhouse; and effectively enhance the people's sense of fulfillment, happiness and security in the cosmetics sector.

By 2030, the legal and regulatory framework for cosmetics regulation will be more complete, the standards system more sound, technical support more robust, industrial innovation vitality stronger, risk prevention and control capabilities comprehensively enhanced, and the level of quality and safety significantly improved. By 2035, the cosmetics quality and safety regulatory system will reach an internationally advanced level, with a regulatory system, regulatory mechanisms, and regulatory approach that are better suited to the intrinsic needs of innovation and high-quality development. The industry's capacity for innovation and global competitiveness will be significantly enhanced, and regulatory modernization will be essentially achieved.

II. Intensifying Support for Innovation in the Cosmetics Industry

(1) Facilitating registration pathways for cosmetics with new efficacy claims. In response to new social consumption demands and emerging industry trends, the Opinions support the registration and filing of cosmetics with new efficacy claims, implement an immediate review upon submission, and introduce a pre-submission consultation mechanism for their registration. The Opinions will also adjust the cosmetics classification rules and catalogue.

(2) Encouraging the new cosmetics' first launch in China. In alignment with international high standards for trade and economic regulations, the Opinions will foster a "first-launch economy" in China's cosmetics sector. For international cosmetics products that are first launched in China, the requirement to submit marketing authorization documents from the country (region) of manufacture will be exempted, in accordance with regulations for products manufactured specifically for export to China.

(3) Promoting the development of the Aging Economy in cosmetics. The Opinions encourage enterprises to strengthen technological R&D for cosmetics designed for "silver-haired" consumers, and support cutting-edge fundamental research on skin-aging mechanisms. The Opinions support the development, application, and registration of cosmetics tailored to the characteristics and needs of the elderly population, addressing the diverse consumption demands of this demographic.

(4) Innovating cosmetics labeling management. In response to the demand for intelligent and green development in the cosmetics industry, the Opinions accelerate the implementation of electronic labeling for cosmetics. The Opinions will establish labeling and data management requirements for electronic labeling for cosmetics, achieving a digital upgrade, refined governance, and convenient services for label management.

(5) Innovating personalized service models. In response to the people's demand for personalized and precision consumption, the Opinions adhere to a demand-driven, safe, controlled, and regulated approach. The Opinions will explore personalized services for cosmetics and allow cosmetics registrants to provide on-site simplified mixing, repacking, and other services for registered ordinary cosmetics based on consumer needs at their distribution premises.

(6) Increasing industry support. Provincial drug regulatory departments are encouraged to actively seek government support and coordinate with relevant departments to introduce policies that support the cosmetics industry. This will create a favorable environment for industry innovation, support the green and low-carbon development of the sector, and empower the rise of brands. Efforts will be made to foster the growth of nationally competitive, internationally recognized cosmetics brands.

III. Enhancing the Efficiency of Cosmetics Registration and Filing Management

(7) Supporting technological innovation in cosmetic ingredients. The Opinions improve the classified management and technical evaluation system for new ingredients; explore the establishment of ingredient nomenclature rules that fit China's national conditions and align with international practice; focus on developing standards for high-use-frequency ingredients, ingredients with prominent safety risks, and ingredients derived from plant resources with Chinese characteristics. The Opinions build a mechanism for R&D–review collaboration to provide end-to-end services of early engagement, process guidance and dynamic optimization for eligible new ingredients.

(8) Optimizing cosmetics registration and filing documentation. While ensuring cosmetics quality and safety and meeting regulatory requirements, the Opinions allow products with similar formulas but differences in components such as colorants or fragrances (in terms of type or content) to share a Material Safety Data Sheet for registration and filing under the same brand. For cosmetics that require re-registration due to changes in the production premises, the original registration and filing technical documentation may be used, except for the microbiological and physicochemical Certificate of Analysis. The Opinions strengthen the primary responsibility of cosmetics registrants and filing entities for quality and safety, and adjust the storage of cosmetic raw material safety-related information to be archived by enterprises for reference.

(9) Improving the quality and efficiency of technical review. The Opinions explore and establish a "NMPA–provincial administration" coordinated review mechanism and delegate certain technical review tasks for special cosmetics to capable provincial drug regulatory departments. Registration changes in special cosmetics will be subject to categorized management: for high-risk changes, the review period will be shortened from 90 to 60 working days; for low-risk changes, to 45 working days. For changes that do not involve safety or efficacy claims, registrants will be permitted to maintain product registration information on their own.

(10) Optimizing the safety assessment system. The Opinions strengthen research and innovation in cosmetics safety assessment technologies, promote the use of advanced assessment techniques and strategies, and continuously improve the technical guidelines to enhance the scientific rigor, precision, and applicability of safety assessments. The Opinions guide and urge cosmetics companies to strengthen the concept of safety assessment, implement full-life-cycle management responsibilities for products, and continually improve the ability to ensure product quality and safety.

(11) Optimizing efficacy claims management. Except for efficacy claims such as spot corrector and whitening, sunscreen, and preventing hair loss, the Opinions allow cosmetics registrants and filing entities to independently select appropriate efficacy evaluation methods for efficacy claims. The Opinions allow similar products within the same brand that differ only in the type or content of ingredients such as colorants, fragrances, or preservatives to share test data of efficacy claims. The Opinions support the associations of the cosmetics industry and other social organizations in strengthening industrial self-discipline, focusing on key efficacy categories of general industry concern, researching guidelines for cosmetics efficacy claims, and guiding the standardization of labeling and claim language.

IV. Improving the Regulatory Mechanism for Production and Marketing of Cosmetics

(12) Advancing graded and classified regulation of enterprises. Local drug regulatory authorities at all levels are encouraged to establish and improve a graded and classified management system for production and marketing of cosmetics based on risk management principles. According to key factors such as enterprises' quality management systems and risk prevention and control capabilities, the Opinions assess risk grades scientifically to allocate regulatory resources more rationally and improve regulatory efficiency effectively.

(13) Optimizing production quality management. The Opinions carry out in-depth actions to enhance the production quality management systems of cosmetics manufacturers, exploring the optimization of production management systems. The goal is to comprehensively improve the operational effectiveness of the enterprises' quality management systems and their ability to ensure product quality and safety. Provincial drug regulatory authorities are encouraged to explore requirements for product release from off-site warehouses operating under the same manufacturing quality management system as the manufacturing site, and quality management requirements that adapt to intelligent cosmetics manufacturing. Efforts will be made to establish a professional title evaluation system for quality and safety experts in cosmetics research and development, production, testing and analysis, and safety and efficacy evaluation.

(14) Strengthening regulation of online business distribution. The Opinions improve mechanisms for "governing the internet via the internet" and continuously optimize the national cosmetics online business distribution monitoring platform to enhance risk identification and monitoring effectiveness. The Opinions hold e-commerce platforms accountable for managing operators within their platforms, continuously strengthen regulatory collaboration and risk-sharing mechanisms, and promote the coordination between administrative regulation and platform governance. This will help identify and resolve potential safety risks of cosmetics. For typical illegal behaviors such as unregistered products, illegal additives, and operators self-compounding cosmetics, the Opinions strengthen key monitoring, thereby improving the quality and safety of cosmetics online business distribution.

(15) Strengthening adverse reaction monitoring and evaluation. The Opinions improve the cosmetics adverse reaction monitoring system, upgrade the monitoring platform's functionality, and strengthen data quality management to improve the accuracy and usability of monitoring data. The Opinions promote the sharing of national adverse reaction monitoring data, ensure that cosmetics registrants and filing entities take responsibility for analysis and evaluation, and further strengthen the deep analysis, scientific evaluation, and risk assessment of monitoring data. This will promote the conversion and application of evaluation results.

(16) Enhancing registration and filing extended regulation. Provincial drug regulatory authorities are encouraged to strengthen the authenticity audit of registration and filing data based on the needs of cosmetics registration and filing. Explore extended inspections to include testing agencies and other relevant entities, and work towards building a full-chain risk prevention and control system.

V. Strengthening Technical Support for Cosmetics Regulation

(17) Strengthening the regulatory team and capacity building. The Opinions strengthen professional technical capacity in cosmetics review, optimize the structure of cosmetics inspector teams, and enhance systematic training, professional management, and scientific performance evaluation for review and inspection personnel. Provincial drug regulatory authorities are encouraged to strengthen exchanges and cooperation, enhance resource sharing, information interconnection, and regulatory collaboration, and actively explore innovative regulatory models. Provincial drug regulatory authorities are encouraged to actively participate in special cosmetics registration, pre-submission consultations for new ingredient registrations, and other related work.

(18) Improving the standard system. The Opinions accelerate the establishment of a scientific, unified, authoritative, and efficient system of cosmetics standard management system and the development of plans for cosmetics standards. The Opinions speed up the development of mandatory national standards with a focus on safety, and strengthen the binding force of basic safety standards. Focusing on key areas and weak links such as ingredient safety control, safety and efficacy evaluation, and the application of emerging technologies, the Opinions precisely fill gaps in the standard system, providing standardized support for the regulated development of the industry and improvements in quality and safety.

(19) Deepening regulatory science research. The Opinions fully utilize regulatory science innovation research bases to focus major research tasks on key areas such as safety assessment, innovative products and ingredients, and risk early warning. The Opinions improve the mechanism for the transformation and application of regulatory scientific research achievements, accelerate the development of new regulatory tools, standards, and methodologies, and enhance the scientific and modern level of regulation.

(20) Strengthen regulatory digital-informatization. The Opinions further enhance the intelligence regulation capabilities for cosmetics, promote the digitalization of the entire cosmetics regulatory business and process, ensure the full online handling of government affairs related to enterprises, optimize and upgrade the cosmetics regulatory APP, and improve the effectiveness of grassroots regulation and public science outreach services. The Opinions improve the information records of cosmetics registrants and filing entities, strengthen data collection and governance, advance scenario applications, and fully utilize the role of archival data in regulation. Provincial drug regulatory authorities are encouraged to accelerate the transformation to intelligence regulation, strengthen the application research of artificial intelligence in cosmetics registration, production, and distribution regulation, and improve the efficiency of regulatory work.

VI. Promoting the Alignment of Cosmetics Regulation with International Standards

(21) Deepening international exchange and cooperation. The NMPA actively participates in the development of technical documents and regulatory coordination under international cosmetics regulatory cooperation frameworks, and establishes and improves a regular mechanism for tracking, assessing, and responding to international regulatory dynamics. The NMPA actively promotes the convergence, coordination, and trust of cosmetics regulation. The associations of the cosmetics industry are encouraged to support the "go-global" efforts of domestic cosmetics and help the international development of China's cosmetics industry.

(22) Advancing alignment of the standards to the international ones. The NMPA strengthens research on international cosmetics standards, accelerates the transformation and application of internationally accepted standards, and promotes the alignment of domestic standards with internationally advanced levels. The NMPA actively participates in and promotes the initiation, research, and formulation of international standards to enhance China’s influence and voice in the field of international cosmetics standards.

(23) Accelerating the reduction and exemption of animal testing. Following the principles of "reduce, replace, optimize", the NMPA accelerates efforts to reduce reliance on animal testing for cosmetics, starting with areas such as perming products, non-oxidative hair dyes, and the use of new ingredients during monitoring periods, then gradually implements animal testing exemptions. The NMPA adheres to the principle of "replace wherever possible" and accelerates the development, transformation, and application of alternative animal testing methods.

(24) Optimizing the management mechanism for permitted ingredients. The NMPA establishes a dynamic updating mechanism for standards related to preservatives, sunscreens, colorants, hair dyes, etc., and supports the inclusion of ingredients that have been scientifically evaluated by international authoritative bodies and have a history of safe use abroad into the domestic permitted ingredients list in a timely manner.

At all levels, drug regulatory authorities shall ensure that the leadership of the Party is firmly embedded throughout the entire process of deepening cosmetics regulation reforms. They shall fully recognize the significant role of these reforms in promoting high-quality industry development and high-level safety. The NMPA shall resolutely implement the "four strictest" requirements, with a strong sense of responsibility and mission, closely integrate the specific circumstances of each region, and comprehensively implement the reform measures and work requirements outlined in this opinion to ensure that all reform tasks are fully carried out and achieve tangible results.

National Medical Products Administration

November 14, 2025