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.

KEYWORDS:

• Traditional and complementary medicine
• proprietary Chinese medicine
• traditional Chinese medicine
• Chinese medicine regulation
• Chinese medicine registration
• product license application regulation

Acknowledgement

We would like to thank the advice from our colleagues at the University of Macau.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work was supported by the Macao Science and Technology Development Fund [grant number 001/2023/ALC and 0006/2020/AKP], the Research Fund of University of Macau [grant number CPG2023-00028-ICMS], Guangxi Science and Technology Major Project [grant number GUIKEAA22096029], and Macao Young Scholars Program [grant number AM2022022].