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關于公開征求《兒童用化學藥品改良型新藥臨床試驗技術指導原則(征求意見稿)》意見的通知

來源:NMPA CDE  發布時間:2021-04-13  瀏覽量:454

關于公開征求《兒童用化學藥品改良型新藥臨床試驗技術指導原則(征求意見稿)》意見的通知

發布日期:20210413

      為鼓勵以我國兒科臨床需求為導向,根據兒童生長發育特點和兒科臨床實踐需要,開發兒童用化學藥品改良型新藥,在已發布的《化學藥品改良型新藥臨床試驗技術指導原則》基礎上,藥審中心起草了《兒童用化學藥品改良型新藥臨床試驗技術指導原則》。經征求中心內部各相關專業及部分研發單位意見,形成征求意見稿。
       我們誠摯地歡迎社會各界對征求意見稿提出寶貴意見和建議,并及時反饋給我們,以便后續完善。征求意見時限為自發布之日起一個月。
       您的反饋意見請發到以下郵箱:
       聯系方式:zhanghao@cde.org.cn
       感謝您的參與和大力支持。
                                                                                                                           國家藥品監督管理局藥品審評中心
                                                                                                                                         2021年4月13日

        附件1:《兒童用化學藥品改良型新藥臨床試驗技術指導原則(征求意見稿)》

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