China’s evidence-based re-evaluation of traditional Chinese medicine injections

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Source: Nature Medicine

Original: https://www.nature.com/articles/s41591-025-04122-7...

Published: 2026-01-08

The article describes that China has begun a systematic and evidence-based review of traditional Chinese medicine (TCM) injections, which have been widely used for many years under relatively loose regulation.[1][2] The impetus was repeated reports of serious adverse effects, including deaths, from multiple TCM injections in 2006–2009, leading to an emergency suspension of some preparations and increasing pressure for evidence of safety and efficacy.[1][2] Strict new rules were introduced in 2025, ordering a reassessment of the safety and efficacy of all TCM injections approved before 2019, and predict that as many as half to two-thirds of these products may disappear from the market.[1][2] The policy takes a multi-tiered approach: it encourages voluntary assessments, requires mandatory re-evaluation of high-risk preparations, and allows for the withdrawal of those that fail modern scientific tests.[1] The regulator created a 28-member expert group led by a prominent TCM expert to guide the reform and technical evaluation criteria.[1][2] The article also mentions the economic context: hospital sales of TCM injections peaked at 21.2 billion yuan in 2016, fell after tightening supervision, and partially recovered to 10.5 billion yuan in 2023.[2] The new regulation is presented as a shift from purely experiential practice to evidence-based medicine in TCM injections, with an emphasis on transparent, independent academic review of all existing preparations.[1][2]