Dataset Information

Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China.

ABSTRACT:

Background

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.

Methods

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.

Results

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.

Conclusion

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.

SUBMITTER: Liu Z

PROVIDER: S-EPMC11020596 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

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Publications

Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China.

Liu Zicheng Z Zhao Jinmin J Wang Yitao Y Luo Hua H

Journal of pharmaceutical policy and practice 20240327 1

<h4>Background</h4>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.<h4>Methods</h4>We conducted a comprehensive review of t ...[more]

PMID: 38628567

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Project description:The Guangdong-Hong Kong-Macao Greater Bay Area urban agglomeration is an urban agglomeration with some of the most intensive urbanization since 1980s. A large amount of cultivated land, forest land, water bodies and other land types in the region has been occupied by construction land, resulting in fragmented ecological landscapes and biodiversity in the region and causing many other ecological problems. Based on this, this paper takes the Guangdong-Hong Kong-Macao Greater Bay Area as a case study, constructs an ecological network of the dispersion scale of five species from 1990 to 2020 based on a morphological spatial pattern analysis (MSPA) method, identifies the ecological groups in the network and uses the core node-based community evolution path tracking algorithm to analyze the ecological groups in order to explore the changes of ecological network connectivity at different scales in the region and to reveal the overall and local characteristics and changes of the migratory space of terrestrial mammals with different dispersion capabilities. The research results show that: (1) From 1990 to 2020, the area of construction land in the Guangdong-Hong Kong-Macao Greater Bay Area increased sharply, with good connectivity in the northwest, southwest and eastern regions and poor connectivity in the central region. (2) There are obvious differences between the overall and local changes in the connectivity trends of multi-scale regional ecological networks. On the whole, the overall ecological connectivity of the ecological network at each scale showed a gradual upward trend, and the overall connectivity index IIC and the possible connectivity index PC gradually increased with the increase of the maximum dispersal distance of species. From the perspective of local patches, the larger the species dispersion scale, the larger the value of the revised betweenness centrality index and the patch possible connectivity index. (3) The distribution of ecological groups at different species dispersion scales is different, and the smaller the dispersal scale of the species, the greater the distribution of ecological groups. Small-scale species are limited by the maximum dispersal distance, and the range of their ecological groups is generally small. Small-scale (3 km), mesoscale (10 km) and large-scale (30 km) core nodes of ecological groups show a gradual increase trend, and the overall connectivity of ecological groups has improved. However, the core nodes of the extra-large-scale (60 km) and ultra-large-scale (100 km) ecological groups show a trend of decreasing fluctuations, and the overall connectivity within the ecological group has declined. This study is helpful to clarify the structural characteristics of regional ecological space and provide a theoretical basis for regional ecological planning.

Dataset Information

Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China.

Background

Methods

Results

Conclusion

Publications

Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China.

Similar Datasets

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