Analysis of Revision Notifications of Traditional Chinese Medicine Injection Leaflets and Relevant Filed Information

OBJECTIVE To analyze the revision notifications of traditional Chinese medicine(TCM) injection leaflets and the relevant filed information of revision, so as to produce evidence to support TCM injection leaflets supervision. METHODS The revision notifications of TCM injection leaflets were compared with the existing data of TCM injection and filed information of revision. A quantitative analysis was conducted on WARNINGS, CONTRAINDICATIONS, ADVERSE REACTIONS and PRECAUTIONS in the TCM injection leaflets revision models/requirements. RESULTS Revision notifications of TCM injection leaflet had risen obviously in recent years, while the notified proportion of the varieties with few licences was low. Approximately 23.7% of the licences of notified varieties was without a filed revision, of which 82.8% needed to be renewed in 2020. Among the 30 leaflets revision models/requirements, WARNINGS almost related to anaphylactic shock. The number of system-organ classes influenced by ADVERSE REACTIONS listed was between 4 to 10, with renal toxicity and liver toxicity less mentioned. TCM syndromes appeared only in 2 revision models/requirements in CONTRAINDICATIONS. PRECAUTIONS were focused on USE IN SPECIFIC POPULATIONS and DRUG INTERACTIONS. The correlation between WARNINGS, CONTRAINDICATIONS, ADVERSE REACTIONS was low. CONCLUSION Constant revision of TCM injection leaflets needs to be made, especially aiming at those varieties with limited approvals. The enterprises should be impelled to shoulder the responsibility of leaflets revision and renewed leaflets use through legal duty specification, entire leaflets disclosure and license renew review by regulators. It is also recommended to improve the revision of ADVERSE REACTIONS, WARNINGS and CONTRAINDICATIONS according to systematic evidence-based researches, to list USE IN SPECIFIC POPULATIONS and DRUG INTERACTIONS as individual items, and to strengthen the connection between the items in the leaflets.