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

Abstract

Background The National Medical Products Administration (NMPA) in China has set to advance the regulatory capacity of traditional Chinese medicines (TCMs) with the adoption of regulatory science (RS). However, the priority of actions at the interface of RS and TCMs were yet to be defined. This research aims to identify the priority areas and summarize core actions for advancing RS for traditional medicines in China. Methods A mixed approach of documentary analysis of government policies, regulations and official information about TCMs regulation in China, and a scoping review of literature using 4 databases (PubMed, ScienceDirect, Scopus and CNKI) on major concerns in TCMs regulation was employed. Results Ten priority areas in the development of TCM-related regulatory science in China have been identified, including: (1) modernizing the regulatory system with a holistic approach; (2) advancing the methodology for the quality control of TCMs; (3) fostering the control mechanism of TCMs manufacturing process; (4) improving clinical evaluation of TCMs and leveraging real world data; (5) re-evaluation of TCMs injection; (6) developing evaluation standards for classic TCMs formula; (7) harnessing diverse data to improve pharmacovigilance of TCMs; (8) evaluating the value of integrative medicine in clinical practice with scientific research; (9) advancing the regulatory capacity to encourage innovation in TCMs; and (10) advancing a vision of collaboration for RS development in TCMs. Conclusions RS for TCMs in China encompasses revolution of operational procedures, advancement in science and technology, and cross-disciplinary collaborations. Such experiences could be integrated in the communications among drug regulatory authorities to promote standardized and scientific regulation of traditional medicines.

Advancing the Regulation of Traditional and Complementary Medicine Products: A Comparison of Five Regulatory Systems on Traditional Medicines with a Long History of Use

“…Last but not least, the discipline of regulatory science, charged with the objectives to enhance the scientific rationale supporting their benefit/risk analysis and regulatory decisions based on best available science [ 90 ], should also be developed and applied to the regulation of TM/CM products [ 91 ]. Regulatory science for TM/CM encompasses revolution of operational procedures, advancement in science and technology, and cross-boundary collaborations and facilitates communications and collaboration between drug regulatory authorities and other stakeholders to promote scientific regulation of TM/CM products.…”

“…Cooperation with universities and research institutes is the pathway to resolve any technical challenges in evaluation and regulation. Based on the experiences in China and Japan [ 91 , 93 ], formulating and providing regulatory training programs is also the core to enhancing the regulatory capacity and facilitating stakeholder communication.…”

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

“…There are corresponding guidelines and applications in drug development, pediatric drugs, medical devices, and quality standard of high-quality RWD. A special application of RWE in China is that unique traditional Chinese medicine empirical formulas could become the scope of practical evidence, including clinical research of Traditional Chinese Medicine, re-evaluation, and effectiveness analysis (55).…”

Clinical and economic analysis of Gastrodin injection for dizziness or vertigo: a retrospective cohort study based on electronic health records in China

“…It must consider realistic comparator drugs to evaluate specific medicine products' clinical and economic effects [ 33 ]. The leveraging of real-world data can improve clinical evaluation and that is one of the priority areas for improving public safety and facilitating innovation in China [ 34 ]. From current literature, there is still lacking studies on the evaluation of curative effect and economic benefit of the Gastrodin injection with the comparison of other drugs for patients in the real clinical environment.…”