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.
Примеры
- ICH E6 (GCP)
- ICH Q3 (Impurities)
- ICH M7 (Mutagenic impurities)
Знаете ли вы?
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.