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                  省藥監局以問題導向促發展——多措并舉為全省醫藥產業發展保駕護航
                  2019-08-30 08:28:00 來源:湖北日報

                  8月27日,省藥監局發布最新一期《藥品GSP認證審查公示》。此次共公示國藥控股湖北江漢有限公司等4家藥企藥品經營質量審查情況。這已是省藥監局在8月發布的第六期相關審查公示。

                  今年是全省藥品批發企業GSP認證換證高峰年,約有400家藥品批發企業GSP證書到期需要換證,在省藥監局開展“不忘初心、牢記使命”主題教育面對面聽取企業意見時,藥企普遍反映申請換證排隊時間長、擔心逾期等問題。“換發GSP認證是核準藥企再次準入經營的手段,也是承認藥品經營企業合法經營的顯著標志。”十堰市九安醫藥有限公司負責人表示,對藥品經營企業來說,此舉也將倒逼企業規范升級,促進企業健康發展。

                  針對企業申報量激增與認證檢查資源不足的矛盾,省藥監局強化“一盤棋”思想,舉全系統之力應對GSP認證高峰,提前發布換證相關信息和工作動態,引導企業做好計劃、有序申報;在檢查中統一標準尺度,優化資源配置;對于現場檢查通過的企業,審評認證部門實行“三快”:快辦、快審、快轉,確保工作環節無縫對接,為企業早日完成審批取得新證節約時間。“建立藥品GSP認證與藥品經營許可、相關變更申請‘并聯’審批機制,實行多個申請一次檢查模式,既節約了認證檢查資源,也減少了企業經營性成本,得到企業的高度肯定。”省藥監局相關負責人表示,針對認證檢查資源不足的問題,省藥監局在全省統一調配藥品GSP認證檢查力量,從各市州局、相關檢驗檢測機構抽調檢查員開展集中認證檢查,緩解省局人力不足壓力。

                  另外,針對藥企反映在推進仿制藥質量與療效一致性評價方面遇到的臨床試驗、資金緊缺等難題,省藥監局積極與全省各地政府及相關部門溝通,傳達仿制藥質量一致性評價相關的新政策規定,并引導企業合理安排工作進度;同時,對一致性評價品種建立監管臺賬,重點監管其質量標準、生產工藝、生產批量和原輔包使用情況的合規性,堅決防止通過評價后藥品質量下滑現象。“充分發揮藥品審評、檢驗檢測在一致性評價中的技術支撐作用,多渠道搭建咨詢交流平臺,鼓勵省內醫療機構優先承接省內生物等效性臨床試驗。”該負責人表示,同時緊密聯系財政、發改、經信、科技、衛健、醫保等部門,力爭相關獎補政策,并積極推薦通過一致性評價的品種列入省級醫保目錄,鼓勵醫療機構優先采購并在臨床上優先使用。

                  截至目前,全省已有397個品種進行了參比制劑進口備案,31%的品種正式啟動了一致性評價工作,共54個品種正式提交國家藥監局受理,相關工作走在全國前列。

                  (湖北日報全媒記者張茜通訊員貢勇斌袁福國)

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