Zhang Jing, Tang Shuchen, Sun Pengqing
School of Law, Tsinghua University, Beijing 100084, China.
Healthcare (Basel). 2025 Mar 7;13(6):588. doi: 10.3390/healthcare13060588.
China's pharmaceutical regulatory framework is undergoing a pivotal shift from a traditional "command-control" model to a "lifecycle regulation" approach, aiming to balance drug safety, innovation, and accessibility. This study systematically examines the evolution, achievements, and challenges of China's regulatory reforms, offering insights for global pharmaceutical governance. Using a mixed-methods approach integrating historical analysis, policy text mining, and case studies, we reviewed the pharmaceutical laws and regulations enacted since 1949, supplemented by case studies (e.g., COVID-19 vaccine emergency approvals) and a comparative analysis with international models (e.g., U.S. FDA and EU EMA frameworks). The data were sourced from authoritative platforms such as the PKULAW database, criminal law amendments, and international regulatory texts. China's regulatory evolution is categorized into four phases: Emergence (1949-1984), Foundational (1985-2000), Deepening Reform (2001-2018), and Lifecycle Regulation (2019-present). The revised Drug Administration Law (2019) institutionalized risk management, dynamic GMP inspections, and post-market surveillance, marking a transition to holistic lifecycle oversight. Key milestones include the introduction of the Vaccine Management Law (2019) and stricter penalties under the Criminal Law Amendment (XI) (2020). China's lifecycle regulation model demonstrates potential to harmonize safety and innovation, evidenced by improved API export compliance (e.g., 15% increase in international certifications by 2023) and accelerated approvals for breakthrough therapies (e.g., domestically developed PD-1 inhibitors). However, challenges persist, including uneven enforcement capacities, tensions between conditional approvals and risk mitigation, and reliance on global supply chains. These findings provide critical lessons for developing countries navigating similar regulatory dilemmas.
中国的药品监管框架正在经历从传统的“命令控制”模式到“全生命周期监管”方法的关键转变，旨在平衡药品安全、创新和可及性。本研究系统地审视了中国监管改革的演变、成就和挑战，为全球药品治理提供见解。我们采用了历史分析、政策文本挖掘和案例研究相结合的混合方法，回顾了自1949年以来颁布的药品法律法规，并辅以案例研究（如新冠疫苗紧急批准）以及与国际模式（如美国食品药品监督管理局和欧盟药品管理局框架）的比较分析。数据来源于诸如北大法宝数据库、刑法修正案和国际监管文本等权威平台。中国的监管演变分为四个阶段：起步阶段（1949 - 1984年）、基础阶段（1985 - 2000年）、深化改革阶段（2001 - 2018年）和全生命周期监管阶段（2019年至今）。修订后的《药品管理法》（2019年）将风险管理、动态药品生产质量管理规范检查和上市后监管制度化，标志着向全面全生命周期监管的转变。关键里程碑包括《疫苗管理法》（2019年）的出台以及《刑法修正案（十一）》（2020年）规定的更严厉处罚。中国的全生命周期监管模式显示出协调安全与创新的潜力，原料药出口合规性的提高（例如，到2023年国际认证增加15%）和突破性疗法审批加速（例如，国产程序性死亡受体1抑制剂）就是证明。然而，挑战依然存在，包括执法能力不均衡、有条件批准与风险缓解之间的矛盾以及对全球供应链的依赖。这些发现为面临类似监管困境的发展中国家提供了重要经验教训。
