国家药监局规定简化备案的牙膏产品 助企业减负增效
Zhong Guo Xin Wen Wang·2025-12-23 06:45

Core Viewpoint - The National Medical Products Administration (NMPA) has announced new regulations to simplify the registration process for toothpaste products, aiming to support industry development and reduce burdens on companies [1]. Group 1: Regulatory Changes - The NMPA's announcement (No. 124 of 2023) outlines the requirements for toothpaste registration, mandating that companies complete the necessary documentation by December 1, 2025 [1]. - Simplified registration applies to toothpaste products with a history of production, sales, and use, allowing companies to use historical safety data in place of toxicological test reports [1]. Group 2: Product Safety and Compliance - For products launched after January 1, 2021, companies can supplement their registration with a safety assessment report, detailing production and sales history, as well as any quality safety incidents or adverse reactions, thus exempting them from submitting oral mucosa irritation test reports [1].

国家药监局规定简化备案的牙膏产品 助企业减负增效 - Reportify