Current status of the spontaneous reporting and classification/coding system for herbal and traditional medicine in pharmacovigilance.

6 According to a domestic statistics on over-the-count H&TM in Japan, reports of adverse events (AEs) have tripled over the past decade, with serious AEs showing an increasing trend. 7 In China, 10 %–15% of the adverse drug reactions (ADRs) identified by the national pharmacovigilance center are known to be related to H&TM. 8 Similarly, a prospective cohort study in a Korean traditional medicine hospital reported that AEs were found in about 10% of the patients who had been prescribed H&TM. 9 Unlike conventional medicines that require active substance screening, preclinical studies, and large-scale clinical trials to get approval for marketing, most H&TM have been used empirically without going through these complicated procedures.

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