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                              讓創新和合規引導疫苗產業健康發展
                              2019-08-13 10:23 來源:中國醫藥報

                              《疫苗管理法》貫徹落實“四個最嚴”要求,將之前分散在多部法律法規中的疫苗管理規定進行整合,按照全生命周期管理的要求,對疫苗研制、生產、流通、預防接種全鏈條作出全面系統的規定。該法堅持問題導向,對疫苗產品實行最嚴格的監管。與此同時,鼓勵疫苗研發創新也是《疫苗管理法》的一大亮點。

                              《疫苗管理法》提出支持疫苗基礎研究和應用研究,支持產業結構的優化、規模化、集約化,支持新型疫苗的研制,其目的在于提升疫苗安全性、有效性、質量可控性,實現疫苗行業的高質量發展。

                              《疫苗管理法》在鼓勵疫苗上市許可持有人不斷加大研發資金投入、持續優化生產工藝、提升質量控制水平的同時,還鼓勵符合條件的醫療機構、疾病預防控制機構依法開展疫苗的臨床試驗。此外,《疫苗管理法》對疫苗審評審批也作出相關規定,其第十九條明確指出,對疾病預防、控制急需的疫苗和創新疫苗,國務院藥品監管部門應當予以優先審評審批。

                              在鼓勵創新的同時,《疫苗管理法》對疫苗注冊工作也提出明確要求。例如,開展疫苗臨床試驗需經審批;在中國境內上市的疫苗,應取得藥品注冊證書,并且提供真實、充分、可靠的數據資料和樣品。《疫苗管理法》在法律層面明確上述要求,是為了從源頭上保證疫苗質量。相應的,對提供虛假數據資料和樣品、騙取藥品證明文件的,《疫苗管理法》也設置了嚴厲的法律責任,不僅對單位進行處罰,更是貫徹了“處罰到人”的要求。

                              除上述要求外,《疫苗管理法》還強調疫苗全生命周期管理,不僅對疫苗研制、生產建立了相關制度,同時對后續的上市后研究、工藝變更、落后品種淘汰等都作出相應制度安排。

                              配合《疫苗管理法》的宣傳貫徹,下一步國家藥監局將完善藥品注冊相關配套制度文件,進一步優化審評審批流程,細化疫苗工藝變更要求,完善相關技術指南體系,配合相關部門落實支持創新等改革措施,共同促進行業創新發展,守護人民群眾用藥安全。

                              (作者系國家藥監局藥品注冊管理司副巡視員)

                              (作者:李芳 編輯:蘭東 責任編輯:龐依依)

                               


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