China is introducing new regulations for traditional Chinese medicine (TCM) injections that require evidence of their safety, efficacy and mechanism of action. The regulations were issued by the National Medicines Administration (NMPA), the National Health Commission and the National Administration of Traditional Chinese Medicine last fall and only cover intramuscular and intravenous forms, not oral drugs.[1][2] Companies must provide scientific evidence or their products will be withdrawn from the market.[1] Any injection approved before 2019 is subject to a mandatory post-market review, including new clinical trials and auditable data for up to five years.[2] According to expert Zhang Boli, about one-third of existing TCM injections meet the new requirements, another third have no efficacy or safety data, and the rest need further research.[1] The regulations are based on the 2019 amendment to the Medicines Administration Act, which introduces stricter standards for all new medicines, including TCM.[1] If oral medications meet clinical needs, injections are not recommended.[1]