事关万亿市场!国家药监局发文
Zhong Guo Zheng Quan Bao·2025-11-17 12:24

Core Viewpoint - The National Medical Products Administration (NMPA) has released an opinion aimed at reforming cosmetics regulation to promote high-quality industry development, with goals set for 2030 and 2035 to enhance regulatory frameworks, innovation, and safety standards [1] Group 1: Industry Innovation Development - The opinion emphasizes support for innovation in cosmetic raw materials, which are crucial for product safety and efficacy. The NMPA has introduced measures to stimulate raw material research and registration [2] - It proposes optimizing the classification and technical evaluation system for new raw materials, establishing naming rules that align with national conditions and international standards, and enhancing standard-setting for frequently used and high-risk raw materials [2] - A collaborative mechanism for research and review will be constructed to provide comprehensive support for new raw materials, improving the quality of research and application [2] Group 2: New Efficacy Cosmetics Registration - The opinion introduces a specialized review channel for new efficacy cosmetics, allowing for immediate review upon submission and establishing a pre-consultation mechanism to guide enterprises [3] - It aims to simplify product management requirements by adjusting classification rules, thereby supporting industry innovation and meeting new consumer demands [3] Group 3: Encouragement of New Product Launches - The opinion encourages the launch of new cosmetics in China, allowing international products to bypass certain documentation requirements, thus facilitating faster market entry [4] - This initiative aims to enhance consumer access to the latest global beauty products and stimulate domestic consumption, shifting from basic needs to quality upgrades [4] Group 4: Registration and Filing Reform - As of October 2025, over 20,000 companies are registered for cosmetics in China, with a market transaction value exceeding 1 trillion yuan in 2024, making it the largest consumer market globally [5] - The opinion outlines three reform measures focused on modernizing regulatory capabilities and improving review efficiency to create a scientific and efficient governance system for cosmetics [5] Group 5: Specific Measures for Registration and Filing - The opinion proposes specific measures to optimize registration and filing management, such as simplifying application materials and allowing similar products to share safety and efficacy evaluation data [6] - It introduces a collaborative review mechanism between national and provincial levels for special cosmetics, reduces review times for high-risk changes, and allows companies to maintain product information independently for non-safety-related changes [6]