Principal Investigator (PI): Hao HU, Professor
Year: 2024
“Drug registration regulation is one key and starting part of whole-life regulation for new drugs, especially for TCM products. From the view of regulatory science, there is a great demand to innovate RWE methodologies for TCM products. Therefore, this project is highly related to the regulatory sciences of TCM.”
Regulatory Science Challenge
The registration application of traditional Chinese medicine (TCM) products as new drugs often meets the challenges of lacking clinical evidence of RCT. Recently, real-world evidence (RWE) has been proposed and experimented as evidence to support new drug registration applications in chemical and biopharmaceutical drugs. At the same time, it is less developed and applied in TCM products.
Drug registration regulation is one key and starting part of whole-life regulation for new drugs, especially for TCM products. From the view of regulatory science, there is a great demand to innovate RWE methodologies for TCM products.
Project Description
This project aims to comprehensively review all the regulatory requirements of using RWE for the registration application of TCM products, and explore the methodological and infrastructure frameworks for developing RWE of TCM products to meet the registration application requirements of TCM products. It is expected that the findings of this project will contribute to the regulatory science subfield of drug registration to enrich the practices of regulatory authorities.
Research Posters
