国家药监局发文深化化妆品监管改革 多举措激发化妆品市场活力

Core Viewpoint - The National Medical Products Administration (NMPA) has released 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 volume 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 evaluation [2]. Group 3: Regulatory Changes - A specialized review channel for new efficacy cosmetics will be established, allowing for immediate review upon submission and providing pre-consultation for registration applications [3]. - The opinion allows international cosmetics that meet certain criteria to bypass the requirement of submitting proof of prior market approval, facilitating faster market entry for new products [3]. Group 4: Registration and Filing Reform - The opinion proposes specific measures to simplify registration and filing management, such as allowing similar products from the same brand to share safety and efficacy evaluation data and reducing the registration burden for products changing production locations [4]. - The review mechanism will be optimized, with high-risk registration changes being processed in 60 working days and low-risk changes in 45 working days, significantly improving approval efficiency [4].