Table 4 Cases of TCM products using HUE to support registration application
Case number | TCM product | Regulatory decision | Classification of TCM registration | Approval procedure | Year of approval | Human-use experience |
|---|---|---|---|---|---|---|
1 | Qingfei Paidu Granules (QFPD, 清肺排毒颗粒) | New medicine approval | 3.2 Other TCMs compound preparations derived from ancient classic famous recipes | Special and emergency response procedure | 2021 | • Study type: multicenter retrospective observational study • Data source: EHR from more than 60 medical institutions in 28 provinces • Study population: 3715 |
2 | Huashi Baidu Granules (HSBD, 化湿败毒颗粒) | New medicine approval | 3.2 Other TCMs compound preparations derived from ancient classic famous recipes | Special and emergency response procedure | 2021 | Study 1 • Study type: single-center non-randomized controlled trial • Study population: 60 Study 2 • Study type: retrospective case series study • Data source: EHR from Wuhan Jinyintan Hospital • Study population: 55 severe COVID-19 patients |
3 | Xuanfei Baidu Granules (XFBD, 宣肺败毒颗粒) | New medicine approval | 3.2 Other TCMs compound preparations derived from ancient classic famous recipes | Special and emergency response procedure | 2021 | Study 1 • Study type: retrospective observational study • Data source: EHR from Hubei Provincial Hospital of Integrated Chinese and Western Medicine and Wuhan Hospital of Traditional Chinese Medicine • Study population: 41 Study 2 • Study type: pilot randomized clinical trial • Study population: 42 |
4 | Sanhan Huashi Granules (散寒化湿颗粒) | New medicine approval | 3.2 Other TCMs compound preparations derived from ancient classic famous recipes | Normal procedure | 2022 | • Study type: retrospective cohort study • Data source: using the real-time Internet information collection application and Centers for Disease Control for the Wuchang District, patient data were collected through patient self-reports and follow-ups • Study population: 721 mild and moderate COVID-19 patients |
5 | Wenyang Jiedu(WYJD, 温阳解毒颗粒) | New medicine approval | 3.2 Other TCMs compound preparations derived from ancient classic famous recipes | Normal procedure | 2024 | • Study type: retrospective observational study • Data source: EHR from Hankou Hospital in Wuhan • Study population: 477 |
6 | Antiwei Granules(ATW, 安体威颗粒) | Approval for phase 3 clinical trial | 1.1 Compound preparations composed of multi-flavor decoction pieces or extracts | Normal procedure | 2024 | • Not found |