摘要
通过文献调研、制度比较和讨论,梳理中国MAH制度的法规和行业现状,以及潜在的挑战和机遇,提出针对性的建议,为全面释放MAH制度红利提供参考。MAH制度红利的长期释放将有赖于上市许可、生产许可、经营许可监管制度的全面协同改革。MAH的选择应基于其履职能力、市场和资源配置的需要来决定。建立灵活的MAH制度,设立清晰的短期和长期政策目标,建立完善的配套法规,促进我国医药行业的长远发展。
Through literature research,regulation comparison and discussion within industry,this paper assesses the MAH regulations and industry status in China,identifies the potential challenges and opportunities,and puts forward targeted suggestions to enlarge the benefits of the MAH system.The long-term benefits of the MAH system will depend on the comprehensive coordinated reform of marketing authorization,manufacturing authorization and distribution authorization systems.The selection of MAH should be based on their ability to perform their duties,and on market and business needs.The author suggests establishing a flexible MAH system with clear short-term and long-term regulatory objectives,and setting up comprehensive supporting regulations to promote the development of China’s pharmaceutical industry.
作者
王芸
WANG Yun(R&D-Based Pharmaceutical Association Committee(RDPAC))
出处
《中国食品药品监管》
2021年第5期46-53,共8页
China Food & Drug Administration Magazine
关键词
上市许可持有人制度
生产许可制度
经营许可制度
监管
药品管理法
marketing authorization holder
manufacturing authorization
distribution authorization
regulation
Drug Administration Law
