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並前往https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m-4-q-common-technical-document-registration-pharmaceuticals-human-use-quality-step-5_en.pdf

ich-m-4-q-common-technical-document-registration ...

Common Technical Document for the Registration of Pharmaceuticals for Human Use -. Quality ... Guidelines Q 6 A ("NCE") and ICH Guideline Q 6 B ("Biotech").

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