William Cheng King Fai*, Elaine Wat and Leung Ping-Chung
The transformation of Traditional Chinese Medicine (TCM) research outcomes is a complex process involving close communication and collaboration between the industry, the academia, the research institutions and governmental regulatory office, aiming to bring innovative scientific achievement of TCM to market. This paper discusses the registration requirements for TCM products in the Guangdong-Hong Kong-Macao Greater Bay Area and highlights regional differences, emphasizing the importance and challenges of transforming research outcomes. Despite the growing research interests in TCM universities, the actual conversion rate of research outcomes from these academic institutions is still much lower than that of pharmaceutical research circles. Stronger cooperation between TCM experts and enterprises is required.
The ultimate goal of TCM research and development is to transform research outcomes into marketable drugs. Different regions have varying market access requirements, which affect research and development costs and timelines. Analyzing the registration systems governing TCM transformation in Mainland China, Hong Kong and Macao, this paper provides solid reference for the effective transformation of TCM research outcomes. It is hoped that the proper establishment of transformation mechanisms which thoroughly observed the regulatory requirements would lead to the healthy development of the TCM industry.
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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
