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Table 2 10 priority areas and core actions summarized for advancing RS in TCMs

From: Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications

  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