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    《疫苗管理法草案》有望出臺,國家擬對疫苗管理單獨立法

    時間:2018-12-23  來源:第九閱讀網  作者:佚名  有:人讀過該文章

    疫苗管理法草案》23日首次提請十三屆全國人大常委會第七次會議審議。草案就疫苗管理單獨立法,突出疫苗管理特點,強化疫苗的風險管理、全程控制、嚴格監管和社會共治,切實保證疫苗安全、有效和規范接種。

    黨中央、國務院高度重視疫苗監管工作,要求加快完善疫苗藥品監管長效機制。疫苗管理單獨立法,有利于進一步提高疫苗管理措施的權威性和穩定性。

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    國家藥監局政策法規司有關負責人介紹,2005年國務院出臺了《疫苗流通和預防接種管理條例》,并于2016年進行了修訂。此次提交審議的疫苗管理法草案,對疫苗研制、生產、流通、預防接種、補償、賠償等以法律形式進行明確規定,有利于建立系統的、全鏈條的疫苗管理制度。

    這位負責人說,草案堅持疫苗的戰略性和公益性,將預防重大疾病疫苗的研制、生產和儲備納入國家戰略。如提出國家制定疫苗行業發展規劃和產業政策,鼓勵生產的規模化、集約化;建立部門協調機制,統籌協調疫苗安全監管工作;進一步加強國家免疫規劃制度,明確實行異常反應無過錯補償機制。

    為體現最嚴格監管,草案提出,國家對疫苗生產實行嚴于一般藥品生產的準入制度。要求疫苗一般不得委托生產,要求法定代表人、主要負責人以及其他關鍵崗位人員具有良好信用記錄,有相應的專業背景、從業經歷。實行疫苗批簽發制度、疫苗責任強制保險。此外,還規定疫苗的臨床試驗應當由三級醫療機構或者省級以上疾控機構實施或者組織實施。

    對疫苗研制、生產、流通、預防接種全過程,草案有關條款明確落實各方責任。國家實行疫苗全程信息化追溯制度,對上市疫苗開展質量跟蹤分析;在流通環節,疾病預防控制機構組織將疫苗配送至接種單位,其他單位或個人不得向接種單位供應疫苗。

    草案明晰監管責任,強化監管能力建設,嚴厲打擊違法行為。要求藥品監管部門和衛生行政部門建立信息共享機制,實行疫苗安全信息統一公布制度;建設國家和省兩級職業化、專業化檢查員隊伍;強化對監管部門和地方政府責任追究,體現疫苗違法行為從重處罰的原則。

    版權聲明:以上文章中所選用的圖片及文字來源于網絡以及用戶投稿,由于未聯系到知識產權人或未發現有關知識產權的登記,如有知識產權人并不愿意我們使用,如果有侵權請立即聯系我們,我們立即下架或刪除。

    (責任編輯:沙拉美優)

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