In February 2021, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the State Health Commission and the State Administration of Medical Insurance issued the Announcement on Ending the Pilot Work of TCM Formula Granules (No. 22, 2021) (hereinafter referred to as the Announcement), which will come into force on November 1, 2021. In order to promote the rational and standardized clinical use of TCM formula granules in medical institutions, ensure medical safety and improve clinical efficacy, the General Office of the NHC and the General Office of the State Administration of Traditional Chinese Medicine (HEREINAFTER referred to as the Notice) recently issued the Notice on Strengthening the Clinical Use and Management of TCM Formula Granules in Medical Institutions.
According to the notice, health and TCM authorities at all levels should attach great importance to the clinical use and management of TCM formula granules in medical institutions, further refine the reasonable and standardized clinical use measures of TCM formula granules in accordance with the principle of "localized" management, and ensure the dominant position of TCM decoction pieces. It is necessary to strengthen the management of trade practices, and the end to unified prescriptions , accepting bribes and other measures and their implementation will be listed into the key contents of hospital inspection.
According to the circular, only approved or registered medical institutions that can provide TCM services can use TCM granule prescriptions, and only doctors who can prescribe TCM decoction pieces and rural doctors can prescribe TCM granule prescriptions. Doctors should inform patients before prescribing TCM granule to ensure patients' right to know and choose. Medical institutions should establish a prescription comment system for TCM formula granules, and timely report suspected adverse reactions to promote standardized and rational application of TCM formula granules.