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並前往https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-annex-i-definitions-rev-4_en.pdf

Guideline on good pharmacovigilance practices (GVP) - Annex I

Adverse reaction; synonyms: Adverse drug reaction (ADR), ... Individual case safety report (ICSR); synonym: Adverse (drug) reaction report .

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