港澳药械跨境委托生产监管实践与探索

Practices and Exploration of Cross-border Commissioned Production Supervision for Pharmaceutical Equipment in Hong Kong and Macao

港澳药械跨境委托生产是粤港澳大湾区医药产业融合发展的重要工作。本文通过分析当前港澳药械跨境委托生产的监管实践,探讨了药品监管创新发展工作的亮点,同时对委托生产监管工作提出了建议。研究发现,药品上市许可持有人制度改革和居民对港澳药品需求是促进跨境委托生产的重要前提,药品监管部门通过制定细化方案、创新“境外持有+境内生产”模式等主要举措推动制度落实,明确委托生产双方的责任和应履行的程序的建议,建立完善粤港澳三地药品监管协作机制。

Cross-border commissioned production of drugs and medical devices in Hong Kong and Macao is crucial for the integrated development of the medical industry in the Guangdong-Hong Kong-Macao Greater Bay Area.This paper analyzes the regulatory practices of cross-border commissioned pharmaceutical production in Hong Kong and Macao,and explores the highlights of innovative development in drug regulation.It provides recommendations for regulatory practices in commissioned production.The research reveals that the reform of the marketing authorization holder system and the demand for Hong Kong and Macao drugs by residents are important prerequisites for promoting cross-border commissioned production.Drug regulatory authorities have implemented measures such as formulating detailed plans and innovating the"overseas holding+domestic producing"pattern to promote the implementation of the system.It is suggested to further clarify the responsibilities of both parties in commissioned production and the procedures to be followed,and to establish an optimized comprehensive collaborative mechanism for drug regulation among Guangdong,Hong Kong,and Macao.