Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China
ABSTRACTBackground 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 jurisdiction...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/20523211.2024.2325516 |
| _version_ | 1797208546484420608 |
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| author | Zicheng Liu Jinmin Zhao Yitao Wang Hua Luo |
| author_facet | Zicheng Liu Jinmin Zhao Yitao Wang Hua Luo |
| author_sort | Zicheng Liu |
| collection | DOAJ |
| description | ABSTRACTBackground 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. |
| first_indexed | 2024-04-24T09:40:31Z |
| format | Article |
| id | doaj.art-fdc7e6e688c54faa9ef619a43960c7fd |
| institution | Directory Open Access Journal |
| issn | 2052-3211 |
| language | English |
| last_indexed | 2024-04-24T09:40:31Z |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj.art-fdc7e6e688c54faa9ef619a43960c7fd2024-04-15T07:22:27ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112024-12-0117110.1080/20523211.2024.2325516Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of ChinaZicheng Liu0Jinmin Zhao1Yitao Wang2Hua Luo3Macau 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 ChinaCollege of Pharmacy, Guangxi Medical University, Nanning, People’s Republic of ChinaMacau 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 ChinaMacau 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 ChinaABSTRACTBackground 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.https://www.tandfonline.com/doi/10.1080/20523211.2024.2325516Traditional and complementary medicineproprietary Chinese medicinetraditional Chinese medicineChinese medicine regulationChinese medicine registrationproduct license application regulation |
| spellingShingle | Zicheng Liu Jinmin Zhao Yitao Wang Hua Luo Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China Journal of Pharmaceutical Policy and Practice Traditional and complementary medicine proprietary Chinese medicine traditional Chinese medicine Chinese medicine regulation Chinese medicine registration product license application regulation |
| title | Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China |
| title_full | Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China |
| title_fullStr | Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China |
| title_full_unstemmed | Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China |
| title_short | Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China |
| title_sort | comparative study on registration application of proprietary chinese medicine in the guangdong hong kong macau greater bay area of china |
| topic | Traditional and complementary medicine proprietary Chinese medicine traditional Chinese medicine Chinese medicine regulation Chinese medicine registration product license application regulation |
| url | https://www.tandfonline.com/doi/10.1080/20523211.2024.2325516 |
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