Table 1 The brief history of TCM injections
From: Traditional Chinese medicine injections: where we are after 80-year development
Year | Events | Description |
|---|---|---|
1941 | Chaihu injection was successfully developed | Chaihu injection marked the birth of TCM injections |
1954 | Wuhan Pharmaceutical Factory put the Chaihu injection into production | The first industrially produced TCM injection in China |
1960s–1980s | TCM injections increased sharply | TCM injection products reached up to 1400 in the 1980s |
1990 | Shuanghuanglian powder injection was developed and produced by industrialization | The first TCM powder injection |
2006 | Yuxingcao injection was urgently stopped in the clinic | Yuxingcao injection caused 2282 ADRs from 2006 to 2008, and 22 people died [14] |
2007 | Released Basic technical requirements for traditional Chinese medicine and natural medicine injections | Requirements in terms of safety, effectiveness and necessity |
2009 | Released Notice on Carrying out the Safety Re-evaluation of Traditional Chinese Medicine Injections | The first time to propose the re-evaluation of TCM injections |
2010 | Proposed seven technical principles to standardize and guide the safety re-evaluation of TCM injections | These principles involve evaluation of non-clinical research, clinical research, production process, quality control, enterprise’s ability to risk control, benefits and risks, risk management |
2017 | Released Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices | Strict the review and approval of injections; Carry out the re-evaluation of injections |
2020 | Some TCM injections were recommended by Diagnosis and Treatment Protocol to treat pneumonia | TCM injections were mainly used to treat severe and critical illness |
2022 | Lianbizhi injection was delisted from the TCM market | The first TCM injection to be delisted due to re-evaluation failure |