{"schema_version":"1.0","type":"article","title":"動物實驗不是消失，而是藥物研發規則開始換代","url":"https://drugnews.com.tw/articles/2026-07-19-nams-regulatory-shift.html","markdown_url":"https://drugnews.com.tw/articles/2026-07-19-nams-regulatory-shift.md","lang":"zh-Hant","date":"2026-07-19","publish_at":"2026-07-19T08:36:00+08:00","updated_at":"2026-07-19","category":"商業分析系列","topic":"臨床與 CMC","tags":["NAMs","CDE","監管科學","類器官","器官晶片","AI 製藥"],"summary":"CDE 的 NAMs 先鋒計畫為藥企與方法開發者開出雙軌入口；真正的考題是可重複、可驗證且被監管接受的人體相關證據。","key_points":[],"facts":[],"sections":[],"references":[{"title":"各公司官網＆公開資料","source":"","date":"","url":""},{"title":"本文為公開監管與產業資料整理，不構成醫療、投資、募資或股票建議。*","source":"","date":"","url":""}],"images":[{"alt":"類器官、器官晶片與新方法學共同組成更接近人體的證據鏈","url":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift/01_NAMs_%E8%97%A5%E7%89%A9%E7%A0%94%E7%99%BC%E4%B8%8D%E5%86%8D%E5%8F%AA%E9%9D%A0%E5%8B%95%E7%89%A9%E5%AF%A6%E9%A9%97.jpg"},{"alt":"CDE 先鋒計畫為藥企與方法開發者設計兩個入口及多個應用場景","url":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift/02_CDE%E5%85%88%E9%8B%92%E8%A8%88%E7%95%AB_%E5%85%A9%E5%80%8B%E5%85%A5%E5%8F%A3%E5%85%AB%E5%80%8B%E5%A0%B4%E6%99%AF.jpg"},{"alt":"FDA、EMA、MHRA 與 CDE 的 NAMs 監管路徑各有不同節奏","url":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift/03_%E5%85%A8%E7%90%83NAMs%E7%9B%A3%E7%AE%A1%E7%AB%B6%E8%B3%BD.jpg"},{"alt":"類器官、器官晶片、CGT、AI 製藥與 CRO 的產業價值鏈可能被重新定價","url":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift/figure-04.jpg"}],"cover_image":"https://drugnews.com.tw/assets/articles/nams-regulatory-shift/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-07-19）。動物實驗不是消失，而是藥物研發規則開始換代。https://drugnews.com.tw/articles/2026-07-19-nams-regulatory-shift.html","disclaimer":"本文僅供產業研究與知識分享，不構成投資、醫療、募資或個股建議。","translations":{"en":"2026-07-19-nams-regulatory-shift-en.html"},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}