Practices and Exploration of Cross-border Commissioned Production Supervision for Pharmaceutical Equipment in Hong Kong and Macao
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.
Hong Kong and Macaopharmaceuticalscross-border commissioned productionregulatory practicesmarketing authorization holder
万方数据
维普
