国家药监局，最新回应！

Core Viewpoint - The article discusses China's regulatory framework and management of fentanyl-related substances, emphasizing strict controls to prevent misuse and illegal distribution [1][2]. Group 1: Regulatory Overview - All fentanyl-related drugs in China are classified as controlled narcotics, with the strictest management implemented by drug regulatory authorities [2]. - Production and operation of fentanyl-related drugs are conducted under a fixed enterprise system, with production based on demand and fixed sales channels [2]. - Export of fentanyl-related drugs is subject to permit management, requiring international verification of trade legality before issuing export permits [2]. Group 2: Production and Export Data - As of 2024, China has approved four types of fentanyl-related drugs for clinical use, with a total production of 100 kilograms of raw materials primarily for domestic medical use and export [1]. - The export volume of fentanyl-related drugs in 2024 is projected to be 12.3 kilograms, mainly to countries such as South Korea, Vietnam, and the Philippines [1]. - China has never exported fentanyl-related drugs to North America [1]. Group 3: Compliance and Future Actions - Regular inspections and special checks are conducted to ensure compliance and identify safety risks in the production and operation of fentanyl-related drugs [2]. - The National Medical Products Administration (NMPA) plans to continue strengthening supervision and management of fentanyl-related drug production and export, ensuring medical needs are met while preventing illegal distribution and misuse [2].