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關于公開征求《化學藥品非處方藥上市注冊技術指導原則(征求意見稿)》意見的通知

來源:CFDE  發布時間:2020-07-06  瀏覽量:1810

 關于公開征求《化學藥品非處方藥上市注冊技術指導原則(征求意見稿)》意見的通知

發布日期:20200706

      為配合《藥品注冊管理辦法》(簡稱:《辦法》)的實施,基于我國非處方藥注冊申報特點,圍繞《辦法》中規定的四種申報情形,我中心組織起草了《化學藥品非處方藥上市注冊技術指導原則》。經中心內部討論,技術委員會審核,征求部分業內專家和非處方藥研發企業的意見后,現形成征求意見稿。
       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聯系人的郵箱:
       聯系人:孫艷喆、耿瑩
       聯系方式:sunyzh@cde.org.cn、gengy@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
                                                                                                                                         2020年7月6日

附件1:《化學藥品非處方藥上市注冊技術指導原則(征求意見稿)》

附件2:《化學藥品非處方藥上市注冊技術指導原則(征求意見稿)》起草說明

附件3:《化學藥品非處方藥上市注冊技術指導原則(征求意見稿)》意見反饋表

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