Table 2.
10 priority areas and core actions summarized for advancing RS in TCMs
| Priority area | Major concerns | Core actions proposed | |
|---|---|---|---|
| 1 | Modernizing the regulatory system with a holistic approach |
(1) Existing regulatory mode (2) Drug lifecycle management |
(1) Innovative regulation mode of drug lifecycle (2) Establishment of drug information traceability information system (3) The Action Plan for Accelerating the Smart Regulation of Drugs |
| 2 | Advancing the methodology for the quality control of TCMs |
(1) Basic research of quality control (2) Innovative quality control methods |
(1) Guiding Principles for Bioassay of TCM (2) Identify and evaluate quality marker |
| 3 | Fostering the control mechanism of TCMs manufacturing process |
(1) Possible variation of quality in product manufacturing process (2) Many control points in TCMs manufacturing process |
(1) Develop a PAT tool such as near-infrared spectroscopy (2) Guidelines for QbD concept |
| 4 | Improving clinical evaluation of TCMs and leveraging real world data | The clinical evaluation of TCMs remains many challenging |
(1) Establishment of TCMs evidence-based Center (2) Initiation of the Evidence-based Capacity Building Project of TCM (3) Guidelines for drug discovery and review supported by real world evidence |
| 5 | Re-evaluation of TCM injection | The risk of TCM injection safety |
(1) Initiation of re-evaluating TCM injection program (2) Guidelines for safety evaluation of TCM injection |
| 6 | Developing evaluation standards for classic TCM formula |
(1) Formulate methods and standards of pharmacy and biology (2) The development of quality markers |
Guidelines for application to the classic TCM formula preparation and substance benchmark |
| 7 | Harnessing diverse data to improve pharmacovigilance of TCMs | Monitoring of drug safety |
(1) Establishment of China Hospital Pharmacovigilance System (2) Establishment of Database of National Center for ADRs Monitoring |
| 8 | Evaluating the value of integrative medicine in clinical practice with scientific research | Research evidence on the efficacy of integrative medicine | Developing guidelines and funding for clinical practice of integrative medicine |
| 9 | Advancing the regulatory capacity to encourage innovation in TCMs |
(1) Technologies of drug discovery (2) Demand for the assessment of new products |
(1) Develop biochemical techniques and cutting-edge technologies for drug discovery (2) Equip new tools, methodologies and techniques for the assessment of new products |
| 10 | Advancing a vision of collaboration for RS development in TCMs | The challenge of drug innovation development requires to cooperate with all stakeholders |
(1) Set up scientific research bases or centers (2) International scientific collaboration |