Liu Zicheng, Zhao Jinmin, Wang Yitao, Luo Hua
Macau Centre for Research and Development in Chinese Medicine, State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, People's Republic of China.
College of Pharmacy, Guangxi Medical University, Nanning, People's Republic of China.
J Pharm Policy Pract. 2024 Mar 27;17(1):2325516. doi: 10.1080/20523211.2024.2325516. eCollection 2024.
Proprietary Chinese medicine (PCM) is widely used in the Guangdong-Hong Kong-Macau Greater Bay Area (GBA) of China. However, the regulatory frameworks and procedures for PCM registration in the region are not well-established, and there are differences among the three jurisdictions. The study is aimed to compare the legal basis, regulatory guidelines, application requirements, and evaluation criteria in each jurisdiction.
We conducted a comprehensive review of the registration application processes for PCMs in the Chinese mainland, Hong Kong, and Macau based on publicly available information from respective regulators.
The study found that the registration application process in the GBA was complex and time-consuming, with differences in requirements and procedures among the three jurisdictions. The study also identified several challenges faced by PCM manufacturers, such as the lack of harmonisation of regulatory requirements and procedures and the requirement of package inserts and labelling for PCM products. The study proposed recommendations for improving the registration process and promoting the development of the PCM industry in the GBA.
This study provides a comprehensive understanding of the PCM product license application procedures and requirements in the GBA, coupled with discernment of their similarities and disparities, equips applicants with the knowledge to formulate an appropriate strategy for obtaining product approval. Exploring potential methods for harmonising the regulatory process stands to benefit manufacturers, regulators, and patients by improving efficiency and curtailing costs.
中成药在中国粤港澳大湾区广泛使用。然而，该地区中成药注册的监管框架和程序尚未完善，且三个司法管辖区之间存在差异。本研究旨在比较各司法管辖区的法律依据、监管指南、申请要求和评估标准。
我们根据各监管机构公开的信息，对中国大陆、香港和澳门中成药的注册申请流程进行了全面审查。
研究发现，大湾区的注册申请流程复杂且耗时，三个司法管辖区在要求和程序上存在差异。研究还确定了中成药制造商面临的若干挑战，如监管要求和程序缺乏协调统一，以及中成药产品对说明书和标签的要求。该研究针对改进注册流程和促进大湾区中成药产业发展提出了建议。
本研究全面了解了大湾区中成药产品许可申请程序和要求，同时辨别了它们的异同，使申请人具备制定适当策略以获得产品批准的知识。探索协调监管流程的潜在方法，有望通过提高效率和降低成本，使制造商、监管机构和患者受益。
