Traditional Chinese medicine (TCM) is a valuable resource unique to China with a long history of human use and clinical practice, which can be analyzed to generate real-world evidence (RWE). The Chinese government has been actively promoting regulatory reform that is in line with the characteristics of TCM, optimizing the clinical evidence system for TCM, and exploring the important role of RWE in supporting the development of new drugs and regulatory decision-making for TCM. This article aims to provide a comprehensive review of the use of RWE in regulatory decisions for TCM. Based on the characteristics of TCM, this study focuses on the application scenarios, challenges, and opportunities of RWE in TCM. And some suggestions are put forward to promote the wider application of RWE in TCM development and supervision.

Real-world data (RWD) and real-world evidence (RWE) have garnered great interest for supporting drug research and development (R&D) by medical researchers and regulators in recent years. The application and development of RWD/E in drug regulatory decision-making have been vigorously promoted in China. This study seeks to provide a broad overview of how RWE has been contributing to drug regulatory decisions in China. In this paper, we review the development of RWD and RWE, summarize key elements that promote application of RWE, introduce relevant methods and guidelines, elaborate on the opportunities and challenges of RWE in regulatory decision-making in China, and put forward suggestions to promote the application of RWE in China\'s regulatory decision-making and to further facilitate innovative drug evaluation and regulation.

Real-world data (RWD) are increasingly used to generate real-world evidence (RWE) of vaccine safety and effectiveness for regulatory purposes. Assessing feasibility of using RWD sources prior to implementing observational studies is recommended. As a use case, we described the process and findings of a feasibility assessment to identify reliable and relevant data sources for monitoring the safety and effectiveness of the AS04-HPV-16/18 human papillomavirus (HPV) vaccine in China.
Iterative multi-step process: (1) targeted literature review and data source mapping; (2) expert opinion from national RWD experts; (3) survey to evaluate the identified data source operational infrastructure; and (4) continuous appraisal of published studies using the identified data source.
The Yinzhou Regional Health Information Platform (YRHIP) was identified as a data source of main interest, based on its large population coverage, high cervical cancer screening rates, and availability of adult electronic immunization records. Field meetings with national RWD experts confirmed its suitability for post-authorization vaccine studies. Survey results showed that exposure data and relevant safety and effectiveness endpoints were recorded and linkable at the individual level across the platform. Iterative appraisal of emerging evidence from the literature corroborated these findings.
This feasibility assessment indicates that the YRHIP has the capacity to capture demographic, exposure, outcome and other data required to generate RWE on HPV vaccine safety and effectiveness in China. Studies using the YRHIP to monitor the AS04-HPV-16/18 vaccine in routine use building on this feasibility assessment are ongoing.

The occupational health of university staff bears great social and economic value for which health utility is an indivisible aspect. Utility is also the primary data for the cost-utility analysis of occupational health programs. Health utility and occupational diseases have not been reported for the university staff in China. In the light of \"Healthy China,\" we conducted this study aiming to (1) estimate the health utility of university staff to inform cost-utility analysis and (2) screen and identify potential occupational diseases for this occupation and examine their impacts on health.
An occupational health survey was conducted in a sample of working-age university staff. Participants were interviewed face-to-face using the WHO Health and Work Performance Questionnaire and the European Quality of Life 5 Dimensions (EQ-5D) instrument to measure health conditions and health utility, respectively. The univariate analysis included the t-test, chi-square test, and correlation techniques. Multivariate generalized linear models were applied to evaluate the significance of each health condition when controlling for other factors.
The sample (n = 154) had a mean age of 40.65 years and consisted of slightly more women (51.30%). Participants attained a mean (standard deviation) health utility of 0.945 (0.073). The most affected domain was anxiety/depression with 62 (40.26%) participants reporting problems, followed by pain/discomfort which captured 60 (37.66%) staff with problems. Thus, pain and psychologically related conditions were prevalent. Multivariate models identified two conditions that can significantly reduce the health utility. The psychological/emotional conditions were associated with a utility loss of -0.067 (95%CI: -0.089, -0.045). The pain in body parts other than the head, neck, and back reduced the utility by -0.034 (95%CI: -0.055, -0.014).
Working-age staff in Chinese universities may have a lower health utility than the general population. Psychological conditions and musculoskeletal pain appear like occupational diseases. With the health utility data available, economic evaluation of cost-utility should follow up to facilitate the implementation of cost-effective programs.

In order to understand this disparity between human use and drugs approved by regulatory agencies, we analyzed botanical drug clinical trials registered at ClinicalTrial.gov to detect trends in current trials and guide future trials. A total of 195 botanical drug clinical trials were registered from 2016 to 2019, of which 81 are phase II or phase II/III. 95% of all phase II and II/III studies were designed with 100 or less participants per arm, indicating a more observational nature due to the limited power to detect differences in outcomes between treatment and control groups. Due to the limited number of participants, efficacy outcome from results may be highly subjective. 14% of the total trials were phase I studies. For botanical drugs with well-documented or extensive history of human use, phase I may not provide significant additional information, and may, therefore, not be necessary. For the trial design, we suggest added-on studies when botanical drugs are used as part of a combination treatment. Additionally, we believe standardized data collection methods and criteria are critical to utilizing the vast collection of human experience as quality evidence to support regulatory approval.