International Council for Harmonisation (ICH)
ICHGlobal body harmonizing pharmaceutical regulatory guidelines across FDA (US), EMA (EU), and PMDA (Japan). ICH guidelines cover Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) topics.
例
- ICH E6 (GCP)
- ICH Q3 (Impurities)
- ICH M7 (Mutagenic impurities)
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Global body harmonizing pharmaceutical regulatory guidelines across FDA (US), EMA (EU), and PMDA (Japan). ICH guidelines cover Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) topics.