各省、自治区、直辖市和新疆生产建设兵团药品监督管理局：
化妆品是满足人民群众对美的需求和高品质生活向往的重要消费品。近年来，药品监管部门积极推进化妆品监管改革，加快完善化妆品监管法规体系，健全监管制度机制，创新监管方式方法，我国化妆品产业蓬勃发展，质量安全水平持续提升。为进一步统筹化妆品高质量发展和高水平安全，更好满足新时代人民群众对美好生活的新期盼，现就深化化妆品监管改革促进化妆品产业高质量发展提出以下意见。
The medical products administrations of all provinces, autonomous regions and municipalities directly under the Central Government, and the Xinjiang Production and Construction Corps：
Cosmetics are essential consumer products that meet people’s pursuit of beauty and high-quality life. In recent years, the drug regulatory authorities have actively advanced cosmetic regulatory reform, accelerated the improvement of the legal and regulatory framework, strengthened supervisory mechanisms, and innovated regulatory approaches. As a result, China’s cosmetics industry has flourished, with continuous improvement in quality and safety levels. To further coordinate high-quality development and a high level of safety, and to better meet the people’s growing expectations for a beautiful life in the new era, the following opinions are proposed on deepening cosmetic regulatory reform and promoting high-quality development of the cosmetics industry.
以习近平新时代中国特色社会主义思想为指导，全面贯彻党的二十大和二十届二中、三中、四中全会精神，落实全面深化改革要求，立足新发展阶段，贯彻新发展理念，构建新发展格局，坚持科学化、法治化、国际化、现代化的监管发展道路，按照“讲政治、强监管、保安全、促发展、惠民生”的要求，着力统筹发展与安全、活力与秩序、质量与效率、监管与服务，进一步增强监管改革的系统性、整体性和协调性，全过程深化化妆品监管改革，全方位筑牢化妆品安全底线，全链条支持化妆品产业高质量发展，加快推进我国从“制妆大国”向“制妆强国”的跨越，切实增进人民群众在化妆品领域的获得感、幸福感、安全感。
Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, these Opinions fully implement the spirit of the 20th National Congress of the Communist Party of China and the Second, Third and Fourth Plenary Sessions of the 20th CPC Central Committee. They adhere to the overall goal of comprehensively deepening reform, adopting new development concepts, building a new development pattern, and pursuing a regulatory path that is scientific, law-based, internationalised, and modernised. In line with the principles of “upholding political integrity, strengthening supervision, ensuring safety, promoting development, and benefiting the people’s livelihood,” efforts will be made to balance development with safety, vitality with order, quality with efficiency, and supervision with service. The reform of cosmetic regulation will be deepened throughout the entire process, safety baselines will be reinforced comprehensively, and the entire industrial chain will be supported to achieve high-quality development. By doing so, China will accelerate its transformation from a major cosmetics-producing country to a cosmetics powerhouse, continuously enhancing the public’s sense of gain, happiness, and security in the cosmetics field.
到2030年，化妆品监管法律制度更加完善，标准体系更加健全，技术支撑更加有力，产业创新活力更加充沛，风险防控能力全面加强，质量安全水平显著提升。到2035年，化妆品质量安全监管体系达到国际先进水平，监管体系、监管机制、监管方式更好适应产业创新与高质量发展的内在要求，产业具有更强的创新创造力和全球竞争力，基本实现监管现代化。
By 2030, the legal and regulatory system for cosmetics will be more comprehensive, the standards system more robust, technical support more powerful, industrial innovation more dynamic, and risk prevention and control capabilities significantly strengthened. By 2035, the regulatory framework, mechanisms, and methods will reach internationally advanced levels, effectively supporting industrial innovation and high-quality growth. The industry will demonstrate stronger creativity and global competitiveness, achieving modernised regulatory governance in essence.
II. Strengthening Support for Innovation in the Cosmetics Industry
（一）畅通新功效化妆品注册渠道。适应社会消费新需求和行业发展新趋势，支持新功效化妆品注册申报，对申报新功效化妆品即报即审。研究建立新功效化妆品注册申报前置咨询机制，适时调整化妆品分类规则与分类目录。
(1)Streamline the registration pathways for new-efficacy cosmetics. In response to emerging consumer demands and new trends in industry development, the registration applications for new-efficacy cosmetics shall be supported, and an ‘immediate review upon submission’ mechanism shall be implemented. Explore creating a pre-submission consultation mechanism for the registration of new-efficacy cosmetics, and the classification rules and catalogues for cosmetics shall be revised timely.
（二）鼓励化妆品新品在中国首发。对标国际高标准经贸规则，培育我国化妆品领域首发经济，对国际化妆品新品在中国首发上市的，参照专为向我国出口生产的相关规定，免于提交在生产国（地区）已上市销售的证明文件。
(2)Encourage the first launch of new cosmetics products in China. In alignment with high-standard international economic and trade rules, ‘first-launch economy’ in China’s cosmetics sector shall be fostered. For innovative international cosmetics whose first launch is in China, the requirement to submit proof of prior marketing in the country or region of manufacture shall be waived, in accordance with the provisions applicable to products manufactured exclusively for export to China.
（三）促进化妆品银发经济发展。鼓励企业加强“银发族”化妆品的技术研发，开展皮肤衰老机理等前沿基础研究。支持适合老年群体特点和需求的化妆品开发应用和注册备案，满足老年群体多样化消费需求。
(3)Promote the development of the ‘silver economy’ in the cosmetics sector. Enterprises are encouraged to strengthen technical R&D for cosmetics designed for the elderly, including conducting advanced fundamental research on mechanisms of skin aging. The development, application, and registration/notification of cosmetic products tailored to the characteristics and needs of aged consumers shall be supported to meet the diverse consumption demands of the elderly population.
（四）创新化妆品标签管理。适应化妆品产业智能化、绿色化发展需求，加快实施化妆品电子标签，制定化妆品电子标签的标注及数据管理要求，实现标签管理的数字化升级、精细化治理和便利化服务。
(4)Innovate cosmetics labelling management. To meet the needs of intelligent and green development in the cosmetics industry, the implementation of electronic cosmetic labels (e-labels) shall be accelerated. Requirements shall be established for e-label presentation and data management, enabling the digital upgrade, refined governance, and more convenient services of cosmetics label management.
（五）创新个性化服务方式。适应公众个性化、精准化消费需求，坚持需求导向、安全可控、规范有序原则，探索化妆品个性化服务路径，允许化妆品备案人根据消费者需求，在经营场所提供已备案普通化妆品的现场简易调配、分装等服务。
(5)Innovate Personalised Service Models. In response to consumers’ growing preference for personalised and targeted consumption, and following the principles of demand orientated, safety controllable, and orderly regulated, a personalised cosmetics service pathway shall be explored. Registrants and notifiers may, upon consumer requests, carry out on-site simple blending and repackaging of notified general cosmetics within their business premises.
（六）加大产业扶持力度。鼓励省级药品监管部门积极争取政府支持，协调相关部门出台化妆品产业扶持政策，营造良好的产业创新环境，支持行业绿色低碳发展，通过政策赋能推动品牌崛起，培育具有国际竞争力的民族品牌化妆品。
(6)Enhance industrial support measures. Provincial medical products authorities are encouraged to actively seek government support and coordinate with relevant departments to introduce supportive policies for cosmetics industry. The aim is to foster a favourable innovation environment for businesses, support green and low-carbon development, empower brand growth through policy incentives, and cultivate nationally developed cosmetics brands with strong international competitiveness.
III. Improving the Efficiency of Cosmetic Registration and Notification
（七）支持化妆品原料技术创新。完善新原料分类管理及技术评价体系，探索建立符合国情且与国际接轨的原料命名规则，聚焦行业使用广、安全风险高及中国特色植物资源原料制定标准。构建研发审评协同机制，对符合条件的新原料设立前置咨询通道，提供早期介入、过程指导、动态优化的全流程服务。
(7) Support technical innovation in cosmetic ingredients. Improve the classification management and technical evaluation system for new ingredients, and explore establishing ingredient nomenclature rules that align with China’s characteristics while maintaining international compatibility. Focus on developing standards for high-risk ingredients that are widely used in the industry, and for ingredients derived from characteristic Chinese botanical resources. Establish a coordinated mechanism between R&D and technical evaluation, building pre-submission consultation channels for eligible new ingredients, and providing full-process services including early-stage engagement, ongoing guidance, and dynamic optimisation.
（八）优化化妆品注册备案资料。在保障化妆品质量安全和满足监管需求的前提下，允许仅着色剂、香精等成分的种类或者含量上存在差异的配方体系近似的同一品牌产品，注册备案时共用产品安全性技术资料。对因生产场地变化需重新注册备案的化妆品，除微生物和理化检验报告外，允许使用原注册备案技术资料。强化化妆品注册人备案人质量安全主体责任，将化妆品原料安全相关信息调整为企业自行存档备查。
(8) Optimise documentation requirements for cosmetics registration and notification. Under the premise of ensuring product quality and safety while meeting regulatory requirements, products under the same brand that share similar formulation systems, with differences only in the types or concentrations of substances such as colorants and fragrances, may share product safety technical dossier for registration and notification. For cosmetics that require re-registration or re-notification due to change of manufacturing site, the original technical dossiers are allowed for submission, except for microbiological and physicochemical test reports. The primary responsibility of cosmetic registrants and notifiers for product quality and safety shall be strengthened, where enterprises are required to archive safety information of cosmetic ingredients for inspection instead of submission.
（九）提高技术审评质效。探索建立“国家局—省局”联合审评协同机制，委托具备能力的省级药品监管部门承担特殊化妆品部分技术审评工作。对特殊化妆品变更事项分类管理，将高风险、低风险变更事项审评时限从90个工作日分别缩短至60个工作日、45个工作日，不涉及安全性、功效宣称的变更事项允许注册人自行维护产品注册信息。
(9) Improve the quality and efficiency of technical evaluation. Explore creating of a joint evaluation mechanism between the National Medical Products Administration (NMPA) and provincial authorities, delegating qualified provincial medical products administration departments to undertake parts of technical evaluation for special cosmetics. Updates of change for special cosmetics shall be managed by risk-based classifications: the review period for high-risk and low-risk changes shall be shortened from 90 working days to 60 and 45 working days respectively. For changes that do not involve safety or efficacy claims, registrants may self-maintain and update product registration information.
（十）优化安全评估制度。加强化妆品安全评估技术研究与创新，推广应用先进评估技术和策略，持续完善化妆品安全评估技术指南，提升评估工作的科学性、精准性和应用性。引导督促化妆品企业强化安全评估理念，落实产品全生命周期管理责任，不断提高产品质量安全保障能力。
(10) Optimise the cosmetic safety assessment system. Strengthen technical research and innovation in cosmetic safety assessment, promote the adoption of advanced assessment methods and strategies, and continuously improve technical guidelines for safety evaluation, to enhance scientific rigor, accuracy, and applicability. Guide and urge cosmetic enterprises to reinforce a safety assessment mindset, implement whole-life-cycle product management responsibilities, and continuously enhance capabilities to ensure product quality and safety.
（十一）优化功效宣称管理。除祛斑美白、防晒、防脱发功效外，允许化妆品注册人备案人自主选择功效宣称评价试验方法进行功效宣称评价。允许仅着色剂、香精、防腐剂等成分的种类或者含量上存在差异的配方体系近似的同一品牌产品，共享功效宣称评价试验数据。支持化妆品行业协会等社会组织加强行业自律，聚焦行业普遍关注的重点功效类别，研究化妆品功效宣称指引，引导规范标签宣称用语。
(11) Optimise efficacy claim management. Except for the efficacies of skin-whitening/spot-removal, sun protection, and anti-hair loss, cosmetics registrants and notifiers are permitted to self-determine appropriate methods for efficacy claims evaluation. Products under the same brand with similar formulation systems, with differences only in types or concentrations of substances such as colorants, fragrances, and preservatives, may share efficacy evaluation data. Cosmetic industry associations and other social organisations are encouraged to strengthen industry self-discipline, focus on key efficacy categories of high industry concern, develop guidance for cosmetic efficacy claims, and promote standardised label terminologies.
IV. Strengthening the Supervision of Cosmetics Manufacturing and Operation
（十二）推动企业分级分类监管。鼓励地方各级药品监管部门按照风险管理的原则，建立健全化妆品生产经营主体的分级分类管理机制。依据企业的质量管理体系、风险防控能力等关键要素，科学评估风险等级，合理配置监管资源，有效提升监管效能。
(12) Promote graded and classified supervision of enterprises. Local medical products authorities at all levels are encouraged to establish and improve graded and classified supervision mechanisms for cosmetic manufacturers and operators in accordance with the principles of risk management. Based on key factors such as enterprises’ quality management systems and risk-prevention capabilities, authorities shall scientifically evaluate enterprises’ risk grades, rationally allocate supervision resources, and effectively enhance regulatory efficiency.
（十三）优化生产质量管理。深入开展化妆品企业生产质量管理体系提升行动，探索优化生产管理制度，全面提升企业生产质量管理体系运行效能与产品质量安全保障能力。鼓励省级药品监管部门探索与生产场地执行同一生产质量管理体系外设仓库的产品放行管理要求和适应化妆品智能化生产的质量管理要求，推动建立化妆品研发与生产、检测与分析、安全与功效评价等质量安全专业人才的职称评定体系。
(13) Optimise manufacturing quality management. Practically implement the initiative of improving manufacturing quality management systems of cosmetic enterprises, explore optimising manufacturing management mechanisms, and comprehensively enhance the operational effectiveness of enterprises’ quality systems and their capability to ensure product quality and safety. Provincial medical products authorities are encouraged to explore product release requirements for off-site warehouses implementing the same production quality management system as the manufacturing site, as well as quality management requirements suitable for intelligent manufacturing of cosmetics. Promote the establishment of professional title evaluation systems for quality-safety professionals engaged in cosmetic R&D, production, testing and analysis, and safety and efficacy assessment.
（十四）强化网络经营监管。健全“以网管网”监管机制，持续优化国家化妆品网络经营监测平台功能，提高风险识别能力和网络监测效能。压实电商平台对平台内经营者管理责任，持续强化监管协作和风险共治机制，推动行政监管和平台治理协同发力，排查化解化妆品安全风险隐患。对未经注册备案、非法添加禁用物质、经营者自行配制等典型违法行为加强重点监测，提升网络经营化妆品的质量安全水平。
(14) Strengthen the supervision of online operations. A “network-based supervision of networks” mechanism shall be. The functions of the National Online Cosmetic Operation Monitoring Platform shall be continuously optimised to enhance capabilities of risk identification and monitoring. E-commerce platforms shall be held closely accountable for managing operators within their ecosystems. Collaborative supervision and co-governance mechanisms for risk prevention shall be reinforced, promoting coordinated approach between administrative supervision and platform governance to identify and resolve potential safety risks of cosmetics. Typical illegal activities such as selling unregistered or unnotified products, adding prohibited substances, or self-formulating cosmetics by operators, shall be targeted for close monitoring, thereby improving the safety level of online market of cosmetics.
（十五）强化不良反应监测与评价。完善化妆品不良反应监测体系，优化升级不良反应监测平台功能，强化数据质量管理，提升监测数据的准确性和可利用性。推动国家不良反应监测数据共享，落实化妆品注册人备案人分析评价的主体责任，进一步强化监测数据的深度分析、科学评价与风险研判，推动评价结果的转化运用。
(15) Strengthen adverse reaction monitoring and evaluation. Improve the cosmetic adverse reaction monitoring system, upgrade the functions of the adverse reaction monitoring platform, and reinforce data quality management to enhance the accuracy and usability of monitoring data. Promote data sharing of nation-wide adverse reaction monitoring, and ensure that cosmetic registrants and notifiers fulfil their primary responsibility for data analysis and evaluation. Further strengthen in-depth data analysis, scientific evaluation, and risk assessment, and promote the application and transformation of evaluation results.
（十六）加强注册备案延伸监管。推动省级药品监管部门根据化妆品注册备案工作需要加强注册备案数据的真实性核查，探索开展对检验机构等的延伸检查，推动构建全链条风险防控体系。
(16) Enhance extended supervision of registration and notification. Provincial medical products authorities shall strengthen verification of the authenticity of registration and notification data according to regulatory needs, and conduct extended inspections of testing facilities and other relevant entities, promoting the establishment of a full-chain risk prevention and control system.
V. Enhancing Technical Support for Cosmetic Regulation
（十七）加强监管队伍和能力建设。充实化妆品审评专业技术力量，优化化妆品检查员队伍结构，强化化妆品审评和检查员队伍系统化培训、专业化管理和科学化考核。鼓励省级药品监管部门之间深化交流协作，加强资源共享、信息互通与监管协同，积极探索监管模式创新。鼓励省级药品监管部门积极参与特殊化妆品注册、化妆品新原料注册备案前置咨询等工作。
(17) Strengthen regulatory workforce and capacity building. Expand the professional and technical capacity for cosmetics evaluation, optimise the structure of the cosmetics inspection workforce, and reinforce systematic training, professional management, and scientific assessment for cosmetics evaluators and inspectors. Provincial medical products authorities are encouraged to deepen mutual exchanges and collaboration, increase resource sharing, information interoperability, and coordinated supervision, and actively explore innovative regulatory models. Provincial authorities are also encouraged to actively participate in pre-submission consultations for the registration of special cosmetics and new cosmetic ingredients.
（十八）完善标准体系建设。加快推进科学、统一、权威、高效的化妆品标准管理体系，研究制定化妆品标准建设规划。加速推进以保障安全为核心的强制性国家标准建设，强化基础安全标准的约束力。聚焦原料安全控制、安全与功效评价、新兴技术应用等重点领域和薄弱环节，精准填补标准体系空白，为产业规范发展和质量安全提升提供标准化支撑。
(18) Improve the standardisation system. Accelerate building a scientific, unified, authoritative, and efficient management system for cosmetics standards, and develop a strategic plan for cosmetics standardisation. Accelarate the development of mandatory national standards focusing on safety assurance, and strengthen the power of enforcement of fundamental safety standards. Focus on key subjects and disadvantaged areas such as ingredient safety control, safety and efficacy evaluation, and emerging new technology applications, targeting gaps in the standardisation system, and providing technical and regulatory foundations for the standardised development and continuous quality and safety improvement of the industry.
（十九）深化监管科学研究。充分发挥化妆品监管科学创新研究基地作用，围绕安全评估、创新产品与原料、风险预警等关键领域，布局重大科研攻关任务。完善监管科学研究成果转化应用机制，加快研发监管新工具、新标准、新方法，提升监管的科学化、现代化水平。
(19) Deepen regulatory science research. Fully leverage the role of innovation and research bases for cosmetics regulatory science . Major scientific research projects will be strategically deployed in critical areas such as safety assessment, innovative products and ingredients, and risk vigilance. Refine transformation and application mechanisms of research outcomes for regulatory science, and accelerate the development of new regulatory tools, standards, and methodologies, in order to advance regulatory science and modernisation levels.
（二十）加强监管信息化建设。进一步提升化妆品智慧监管能力，推动化妆品监管全业务全流程数字化，涉企政务事项全环节全流程在线办理，优化升级化妆品监管APP，提升服务基层监管效能和公众科普服务水平。完善化妆品注册人备案人信息档案，强化数据汇集与治理，推进场景应用，充分发挥档案数据在监管中的作用。鼓励各省级药品监管部门加快智慧化转型，加强人工智能在化妆品备案、生产和经营监管等领域的应用研究，提升监管工作效率。
(20) Strengthen the digitalisation of regulatory systems. Further enhance the smart regulation capabilities for cosmetics, advance full-process digitalisation of regulatory operations, and ensure all administrative processes involving enterprises are handled online. Upgrade the cosmetic regulatory mobile application (APP) to improve grassroots enforcement efficiency and public education services. Improve the information archives of cosmetic registrants and notifiers, strengthen data aggregation and governance, and promote scenario-based applications, to fully utilise archival data in regulatory activities. Provincial medical products authorities are encouraged to accelerate digital transformation, advance research on the application of artificial intelligence in cosmetic notification, manufacturing, and operation supervision, in order to improve regulatory efficiency.
VI. Promoting International Alignment of Cosmetic Regulation
（二十一）深化国际交流与合作。深度参与国际化妆品监管合作组织框架下的技术文件制定与监管协调，建立健全国际化妆品监管动态的常态化跟踪、研判与响应机制。积极推动化妆品监管趋同、协调和信赖，鼓励化妆品行业协会等社会组织服务国产化妆品“出海”，助力中国化妆品产业国际化发展。
(21) Deepen international exchange and cooperation. Actively participate in technical documents development and regulatory coordination within the frameworks of the International Cooperation on Cosmetics Regulation (ICCR). Establish and refine mechanisms for continuous tracking, analysis, and response to global regulatory updates. Actively promote regulatory convergence, coordination, and mutual trust. Social organisations such as industry associations are encouraged to facilitate Chinese cosmetics enterprises’ “going global”, thereby supporting the global development of China’s cosmetics industry.
（二十二）提升标准国际化水平。深化国际化妆品标准体系研究，加快国际通行标准转化与应用，推动国内标准与国际标准接轨。积极参与并推动国际标准的立项、研究与制定，增强我国在国际化妆品标准领域的影响力和话语权。
(22) Elevate standards for internationalisation. Deepen research on international standard systems for cosmetics, and accelerate the transformation and application of internationally accepted standards, in order to align domestic standards with international ones. Actively participate in and promote the proposal, research, and development of international standards, in order to increase China’s global influence and voice for cosmetics standards.
（二十三）加快推进动物试验减免。遵循“减少、代替、优化”原则，加快推动减少化妆品动物试验依赖，从烫发、非氧化型染发和使用监测期新原料的化妆品等着手，逐步推行动物试验豁免。坚持“能转尽转”，加速动物替代试验方法开发、转化和应用。
(23) Accelerate the reduction and exemption of animal testing. In line with the principles of reduction, replacement, and refinement (‘the 3Rs’), accelerate efforts to reduce reliance on animal testing for cosmetics. Beginning with perming products, non-oxidative hair dyes, and cosmetics using new ingredients that are within the monitoring period, gradually expand the scope of animal testing exemptions. Adhering to the principle of ‘validation wherever possible,’ accelerate the development, validation, and application of alternative test methods.
（二十四）优化准用原料管理机制。建立防腐剂、防晒剂、着色剂、染发剂等的标准动态更新机制，支持将经国际权威机构科学评估、具有国外安全使用历史的原料，及时纳入我国准用原料目录。
(24) Optimise the management mechanism for permitted ingredients. Establish a mechanism for the dynamic revision of standards for preservatives, sunscreens, colorants, and hair dyes. Support the timely inclusion of ingredients that have undergone scientific safety evaluations by internationally authoritative organisations and have a documented history of overseas safe use into China’s catalogue of permitted cosmetic ingredients.
各级药品监管部门要把坚持和加强党的领导贯穿于深化化妆品监管改革的各方面和全过程，深刻认识深化化妆品监管改革对推动产业高质量发展和高水平安全的重大意义，坚决贯彻“四个最严”要求，以高度的责任感和使命感，紧密结合本地区实际，全面落实本意见提出的各项改革举措和工作要求，确保各项改革任务落实到位、取得成效。
Medical products authorities at all levels shall uphold and strengthen the Party’s leadership throughout all aspects and the entire process of deepening cosmetic regulatory reform. They must fully recognise the strategic significance of such reform in promoting high-quality industry development and ensuring a high level of safety, resolutely implement the ‘four strictest’(strictest standards, strictest supervision, strictest punishment, and strictest accountability) requirements, and carry out reform with a strong sense of responsibility and mission. Based on local conditions, all regions shall thoroughly implement the reform measures and work requirements set forth in this document, ensure that all tasks are effectively executed, and achieve substantive results.
（本文由中国香妆协会协会国际事务部柯如编译，仅供行业参考。）
