国家药监局发文深化化妆品监管改革 24项举措激发万亿化妆品市场新活力

Core Viewpoint - The National Medical Products Administration (NMPA) has issued an opinion aimed at deepening the reform of cosmetics regulation and promoting high-quality development in the industry over the next 5 to 10 years, with 24 reform measures proposed to enhance safety and innovation in the cosmetics sector [1][2]. Group 1: Industry Overview - China is the world's largest cosmetics market, with over 20,000 cosmetics companies and 4.6 million registered special cosmetics varieties, alongside 2.29 million filed ordinary cosmetics varieties [1]. - The domestic cosmetics market is projected to exceed 1 trillion yuan in transaction value by 2024, with domestic brands holding a market share of 55.2% [1]. Group 2: Reform Measures - The opinion outlines 24 reform measures focusing on five areas: encouraging innovation, optimizing registration and filing management, strengthening risk prevention across the supply chain, enhancing smart regulatory capabilities, and aligning regulations with international standards [2]. - Specific measures include supporting raw material innovation, establishing a classification management and technical evaluation system for new raw materials, and creating a collaborative mechanism for research and review to improve the quality of research and application [2]. Group 3: Regulatory Changes - The NMPA will set up a special review channel for new efficacy cosmetics, implementing immediate review processes and establishing a pre-consultation mechanism for registration applications, thereby adapting to new consumer demands and industry trends [3]. - The opinion allows international new cosmetics that meet certain criteria to bypass the requirement of submitting sales license proof, facilitating faster market entry and enhancing consumer access to global beauty products [3]. Group 4: Registration and Filing Reform - The opinion proposes specific measures to optimize registration and filing management, such as simplifying application materials and allowing similar products from the same brand to share safety and efficacy evaluation data [4]. - The review mechanism will be optimized, with a collaborative review system between national and provincial levels, and reduced review times for high-risk and low-risk registration changes [4]. - The NMPA plans to implement these reforms within three years, aiming to enhance the production quality management system in the cosmetics industry [4].