Objective: To summarize and analyze the application of traditional technology in preparing traditional Chinese medicine (TCM) preparations in medical institutions in Shaanxi Province after implementing the “Implementation Rules for the Record Management of Traditional Chinese Medicine Preparations in Medical Institutions in Shaanxi Province (Trial)” (“Implementation Rules”), and to provide a reference for the filing of TCM preparations. Methods: The TCM preparations recorded by medical institutions in Shaanxi Province since March 2019 were statistically summarized. The filing status was comprehensively and systematically analyzed based on the number of institutions and preparations, the ratio of commissioned to self-production, dosage form distribution, and the level of medical institutions. Results: Since implementing the Implementation Rules, a total of 479 TCM preparations have been filed in the province. Among these, 262 were commissioned for production, and 217 were self-produced, covering 17 dosage forms such as granules, pills, capsules, mixtures, and powders. A total of 86 medical institutions have filed preparations, most of which are located in Xi’an, Xianyang, and Weinan, with these three cities accounting for the largest number of filings. Conclusion: The policy on the TCM preparation filing system has been widely recognized and deeply implemented in Shaanxi Province. Third-level medical institutions are the primary contributors to preparation filings. Regional differences exist in the development of preparation filing, indicating significant potential for further growth in the province’s filing efforts.
State Food and Drug Administration, 2005, Administrative Measures for the Registration of Pharmaceutical Preparations in Medical Institutions (Trial) (Order No. 20 of the Bureau), viewed July 29, 2024, https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfgbmgzh/20050622010101621.html
Shen X, 2017, Discussion on Relevant Issues of the “Administrative Measures for the Registration of Pharmaceutical Preparations in Medical Institutions (Trial)”. China Pharmacy, 28(25): 3471–3474.
Liu D, He X, Ni S, et al., 2024, Considerations on Pharmaceutical Changes in the Transformation of Traditional Chinese Medicine Preparations in Medical Institutions Based on Human Experience into New Drugs. China J Chin Materia Medica, 49(2): 565–568.
National People’s Congress, 2016, Law of the People’s Republic of China on Traditional Chinese Medicine, viewed, July 29, 2024, http://www.npc.gov.cn/npc/xinwen/2016-12/25/content_2004972.html
State Food and Drug Administration, 2018, Announcement of the General Administration of Food and Drug on the Implementation of Filing Management for the Preparation of Traditional Chinese Medicine Preparations by Medical Institutions by Applying Traditional Techniques, viewed July 29, 2024, https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/ggtg/qtggtg/2018-0212143401381.html
Zhang B, Li W, Li Q, et al., 2020, Discussion on Relevant Issues of the “Announcement on the Implementation of Filing Management for the Preparation of Traditional Chinese Medicine Preparations by Medical Institutions by Applying Traditional Techniques”. Xinjiang J Tradit Chin Med, 38(4): 60–63.
Shaanxi Provincial Drug Administration, Shaanxi Provincial Administration of Traditional Chinese Medicine, 2019, Implementation Rules for the Filing Management of the Preparation of Traditional Chinese Medicine Preparations by Applying Traditional Techniques in Shaanxi Provincial Medical Institutions (Trial), viewed July 29, 2024, http://mpa.shaanxi.gov.cn/info/1006/1198.htm
Zhang L, Cao H, Zhao X, et al., 2021, Analysis of the Current Situation and Countermeasures of the Development of Pharmaceutical Preparations in Shaanxi Provincial Medical Institutions. China Pharmaceuticals, 30(17): 21–23.
Shen W, Hao W, Wang J, et al., 2021, Research on the Current Situation and Countermeasures of the R&D of Traditional Chinese Medicine Preparations in Shaanxi Provincial Medical Institutions. Clin J Tradit Chin Med, 13(25): 131–134.
Du X, Wei X, Cui N, et al., 2023, Analysis of the Use of Pharmaceutical Preparations in a Hospital from 2018 to 2021. China Prescription Drug, 21(3): 49–51.
Liu C, Liu X, Xue Q, et al., 2024, Brief Analysis of the Current Situation and Development of Domestic Pharmaceutical Preparations in Medical Institutions in the Past Decade. China J Tradit Chin Med Pharm, 39(2): 999–1003.
Shaanxi Provincial Health Commission, 2023, Statistical Bulletin on the Development of Health Services in Shaanxi Province in 2022, viewed July 29, 2024, http://sxwjw.shaanxi.gov.cn/zfxxgk/fdzdgknr/tjxx/202306/t20230630_2292362.html
Shaanxi Drug Administration, 2024, Notice of Shaanxi Provincial Drug Administration on Soliciting Public Opinions on the “Implementation Rules for the Filing Management of Traditional Chinese Medicine Preparations Prepared by Applying Traditional Techniques in Shaanxi Provincial Medical Institutions (Draft for Soliciting Opinions on Revision),” (Shaanxi Drug Administration Letter [2024] No. 78), viewed July 29, 2024, https://mpa.shaanxi.gov.cn/info/1187/48494.htm
Shaanxi Provincial Medical Insurance Bureau, 2023, Notice of Shaanxi Provincial Medical Insurance Bureau on Including Some Therapeutic Pharmaceutical Preparations in Medical Institutions in the Scope of Medical Insurance Payment (Shaanxi Medical Insurance Issuance [2023] No. 25), viewed July 29, 2024, http://ybj.shaanxi.gov.cn/gk/tzgg/28621.htm
Wu Z, 2024, Strengthening the Management of the Dispensing and Use of Traditional Chinese Medicine Preparations in Jiangxi Medical Institutions. J Tradit Chin Med Manag, 32(8): 39.
Xu S, Liu Z, 2023, 195 Traditional Chinese Medicine Preparations in Jilin Can be Dispensed Within the Province. J Tradit Chin Med Manag, 31(13): 96.
Dai C, Lin T, 2022, Thoughts on the Inclusion of Traditional Chinese Medicine Preparations in Medical Institutions in Medical Insurance Payment. Chin Pharm Affairs, 36(11): 1308–1314.
Ma Z, Ouyang H, Ni J, et al., 2024, Current Situation of Traditional Chinese Medicine Preparations in Medical Institutions and Its Enlightenment on the R&D Path of New Traditional Chinese Medicine Drugs. China J Chin Materia Medica, 49(5): 1415–1420.
Liu X, Shao M, Fu Y, et al., 2023, Problems and Strategies in the Development of Traditional Chinese Medicine Hospital Preparations. World Sci Technol Modern Tradit Chin Med, 25(5): 1782–1787.
Ming A, Yu S, 2024, Comparative Study on the Filing Management of Traditional Chinese Medicine Preparations in Medical Institutions. Asia-Pac Tradit Med, 20(3): 247–251.