芬太尼类物质管控

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国家药监局,最新回应!
证券时报· 2025-03-12 12:19
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].
国新办,最新发布!外交部发声!
券商中国· 2025-03-04 11:18
Core Viewpoint - The white paper titled "China's Control of Fentanyl-Related Substances" outlines China's comprehensive measures to manage fentanyl substances, emphasizing the dual approach of ensuring reasonable medical use while implementing strict controls to combat illegal activities related to these substances [1][2][3]. Group 1: Definition and Regulation - Fentanyl is defined as a potent synthetic opioid, effective for pain management, with a potency up to 100 times that of morphine [9]. - China has included fentanyl-related drugs in the "Directory of Narcotic Drugs," implementing strict regulations across production, operation, usage, and export [2][14]. - The country has established a traceability system utilizing advanced technologies like IoT and AI to monitor the entire lifecycle of fentanyl-related drugs [2][16]. Group 2: Combating Illegal Activities - China has intensified efforts to combat illegal activities related to fentanyl, including increasing the number of controlled substances and enhancing daily supervision [17]. - The country has implemented a comprehensive legal framework to support the crackdown on fentanyl-related crimes, including the establishment of a classification system for precursor chemicals [20][21]. - Since the implementation of the comprehensive control measures in 2019, there have been no reported cases of fentanyl trafficking to foreign countries [19]. Group 3: Technological Advancements - China has developed a nationwide laboratory system for drug analysis, enhancing capabilities in monitoring and assessing the risks associated with fentanyl [24]. - The establishment of a screening system for unknown substances has been initiated, utilizing advanced analytical techniques to identify new fentanyl variants [25]. - The country has also focused on improving detection methods for drug abuse, including wastewater analysis to monitor drug consumption patterns [26]. Group 4: Global Cooperation - China advocates for a collaborative international approach to tackle the fentanyl crisis, emphasizing mutual assistance and shared responsibilities among nations [31][32]. - The country has engaged in bilateral and multilateral cooperation with over 30 countries, signing numerous agreements to enhance drug control efforts [32][33]. - China actively participates in international drug control initiatives, sharing experiences and technical expertise to address the global fentanyl challenge [35].