Principal Investigator (PI): Carolina, Oi Lam UNG, Assistant Professor
Year: 2024
“Regulatory science of TCM is not only an emerging frontier discipline applied in the field of TCM supervision, but also a new strategy and new paradigm for convergence science of traditional Chinese and Western medicine. As a national-level highland for the construction of the TCM industry, it is critical for the Guangdong-Hong Kong-Macao Greater Bay Area to develop a regulatory science development strategy based on existing regulatory approaches to avoid the unnecessary delays throughout the entire life cycle of TCM healthcare products in line with the unique global market value of TCM healthcare products.”
Regulatory Science Challenge
Traditional Chinese medicine (TCM) is a health resource with originality and advantages in China, and it has played an irreplaceable and important role in protecting people’s lives and health. In recent years, China has attached great importance to the innovation of TCM, and has provided numerous policy guidance from strategic top-level design, legal systems to practical guiding principles for the research and development of TCM new drugs. However, the research and development of TCM involves cross-discipline complexity and strong policy sensitivity. From the cultivation to clinical use of TCM, lots of challenges appear at different stages of TCM development due to its complex scientific, technological and clinical characteristics. These stages include basic product research, product development, approval for marketing, market access and clinical application. Improving the regulatory systems strengthening (RSS) of TCM healthcare products is crucial to ensure that the regulatory system is fit for purpose and efficient, and to promote patients’ access to safe and effective pharmaceutical products. Therefore, this project aims to systematically analyze the strategies to promote the development of TCM healthcare products in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) from the perspective of RSS.
Project Description
This project aims to systematically analyze the development strategies required to transform TCM health products into treatments accessible to patients in GBA from the perspective of RSS, and to adopt a coordinated approach involving engagements of all key stakeholders within the GBA, resulting in a more effective product translation research.
This in-depth research report starts from the actual situation of the GBA, benchmarks against international advanced regulatory concepts and regulatory practices, and integrates the common opinions and suggestions of various stakeholders in the big health industry, academia and government supervision. It is of great practical significance for promoting the TCM healthcare industry in the GBA, satisfying the public and patients’ needs in actual clinical use of TCM healthcare products. This report also provides practical reference for promoting the issuance of regulatory policies/regulations related to TCM in Macao and the future strategies of high-quality development of TCM healthcare industry.
Research Posters
