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Notice of the National Health and Family Planning Commission on Work concerning Canceling the Import and Export Approval of Human Blood, Tissues and Organs [Effective]
國家衛生計生委關于取消人體血液組織器官進出口審批有關工作的通知 [現行有效]
【法宝引证码】

Notice of the National Health and Family Planning Commission on Work concerning Canceling the Import and Export Approval of Human Blood, Tissues and Organs 

國家衛生計生委關于取消人體血液組織器官進出口審批有關工作的通知

The health and family planning commissions of all provinces, autonomous regions, and municipalities directly under the Central Government; and the Health Bureau of Xinjiang Production and Construction Corps: 各省、自治區、直轄市衛生計生委,新疆生產建設兵團衛生局:
For the purpose of implementing the requirements of the State Council for reforming the administrative approval system, in accordance with the Decision of the State Council to Cancel a Group of Administrative Licensing Items (No. 46 [2017], State Council), the National Health and Family Planning Commission has decided to cancel the import and export approval of human blood, tissues and organs. You are hereby notified of the relevant work as follows: 為貫徹落實國務院行政審批制度改革要求,根據《國務院關于取消一批行政許可事項的決定》(國發〔2017〕46號),我委決定取消人體血液、組織器官進出口審批。現就有關工作通知如下:
I. In accordance with the Decision of the State Council to Cancel a Group of Administrative Licensing Items法小寶, the National Health and Family Planning Commission's import and export approval of human blood, tissues and organs shall be canceled.   一、根據《國務院關于取消一批行政許可事項的決定》,取消我委人體血液、組織器官進出口審批。
II. Medical institutions shall not use human blood (including plasma and other blood components), tissues and organs from overseas sources for clinical care purposes.   二、醫療機構禁止使用境外來源的人體血液(包括血漿及其他血液成分)、組織器官用于臨床醫療用途。
III. Where blood or special blood components (such as hematopoietic stem cells in peripheral blood, hematopoietic stem cells in bone marrow, or hematopoietic stem cells in umbilical cord blood) need to be imported for use by a domestic medial institution or be exported to an overseas medical institution for humanitarian purposes or for “healing the wounded and rescuing the dying,” the Red Cross Society of China shall handle the exit-entry formalities in accordance with the current provisions and channels.   三、出于人道主義、救死扶傷的目的,對于血液及特殊血液成分(如:外周血造血幹細胞、骨髓造血幹細胞、臍帶血造血幹細胞等)國內醫療機構需要使用並辦理入境或者境外醫療機構需要辦理出境的,由中國紅十字會總會按照現行規定及途徑辦理出入境手續。
IV. The import and export of human blood, tissues and organs used for scientific research and other purposes shall be governed by the provisions on the “collection, gathering, trade, export, and exit approval of human genetic resources” by the Ministry of Science and Technology and the “exit-entry health quarantine approval of special articles” by the General Administration of Quality Supervision, Inspection and Quarantine.   四、用于科研及其他用途的人體血液、組織器官進出口,按照科技部“人類遺傳資源采集、收集、買賣、出口、出境審批”和質檢總局“出入境特殊物品衛生檢疫審批”的相關規定辦理。
V. All regions shall, in strict accordance with the requirements of the Law of the People's Republic of China on Blood Donation and other relevant laws and regulations, strengthen the administration of blood collection and supply at blood stations and use of clinical blood in medical institutions, and organize technical inspections on the safety of blood on a regular basis under the principle of “inspection of randomly selected entities by randomly selected inspectors and public disclosure of inspection results” to guarantee the safety and supply of blood.   五、各地要嚴格按照《中華人民共和國獻血法》等有關法律法規要求,加強血站采供血、醫療機構臨床用血管理,按照“雙隨機一公開”原則,定期組織血液安全技術核查,保障血液安全和血液供應。
VI. All regions shall practically implement the Regulation on Human Organ Transplantation and other relevant regulations and policies, profoundly promote donation of human organs, continue to increase the supply and enhance the use of tissues and organs, and meet the needs of the people for medical services. At the same time, all regions shall continue to improve the regulatory mechanism that closely integrates supervision based on information technology and big data with point-to-point unannounced inspections, and provide cooperation with public security authorities in crackdown on violations of laws and regulations.   六、各地應當貫徹落實《人體器官移植條例》等有關法規政策,深入推進人體器官捐獻工作,不斷增加組織器官供給並提高利用率,滿足人民群眾醫療服務需求。同時,不斷完善大數據信息化監管與點對點飛行檢查緊密結合的監管機制,配合公安部門嚴厲打擊違法違規行為。
National Health and Family Planning Commission 國家衛生計生委
December 13, 2017 2017年12月13日
     
     
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