Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China
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. From the Abstract
Urbanization impacts on sequential flood-heatwave events in the Guangdong-Hong Kong-Macao Greater Bay Area
Urbanization has been shown to significantly increase the frequency and intensity of extreme weather events, i.e., extreme precipitation events, and heatwave events. Actually, the occurrence of compound extreme events, such as sequential flood-heatwave (SFH) events, can lead to more severe impacts than singular extreme events. However, the impact of urbanization on these compound extreme events is not well understood. In this study, we examine urbanization effects on the change of SFH events during 1961–2017 in the Guangdong-Hong Kong-Macao Greater Bay Area, China. The results showed that the frequency of SFH events in urban areas increased from 0.218 events per year before the 1990s to 1.401 events per year after the 1990s, while the frequency of SFH events in rural areas increased from 0.250 events per year to 0.920 events per year. The urban contribution of 0.131 events per decade also shows that urbanization can significantly promote the occurrence of SFH events. Furthermore, our analysis indicates that urbanization promotes the growth of SFH events mainly by increasing the frequency of heatwave events. These findings highlight the need for further research on the effects of urbanization on compound extreme events and the development of effective management strategies to reduce their risks. From the Abstract
