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干细胞保存合法吗?英文双语对照

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干细胞保存合法吗?英文双语对照

干细胞保存不合法的。一、根据卫生部《脐带血造血干细胞库管理办法(试行)》规定,脐带血造血干细胞库的设置审批由卫生部负责,未经卫生部批准,任何机构一律不得开展脐带血造血干细胞采集工作。

开展脐带血造血干细胞研究,必须严格执行科研管理和临床试验研究的有关规定,任何机构不得以科研为目的违规采集脐带血造血干细胞及违规经营。 二、脐带血造血干细胞治疗技术属第三类医疗技术,医疗机构未经审核批准,一律不得开展临床应用。获准开展该项技术临床应用的医疗机构必须严格执行卫生部印发的《脐带血造血干细胞治疗技术管理规范(试行)》等规范性文件.

将该项治疗技术临床应用严格控制在治疗血液系统疾病范围,并只能接受具有执业许可证的脐带血库提供的脐带血。任何医疗机构不得协助无执业许可证的机构采集脐带血。 三、各医疗机构必须严格执行《医疗广告管理办法》规定,在取得《医疗广告审查证明》后,按照《医疗广告审查证明》核准的广告成品样件内容与媒体类别发布医疗广告。

各级卫生行政部门要严格医疗广告审查与管理,加强医疗广告监测,主动加强与工商管理部门的沟通、协调,切实加强对辖区内脐带血造血干细胞治疗技术相关广告的监管力度,坚决依法依规查处违法发布虚假医疗广告的行为。 四、各级卫生行政部门要切实履行职责,严格按照《脐带血造血干细胞治疗技术管理规范(试行)》等相关法律、法规和规范性文件要求,进一步加强对脐带血造血干细胞采集和临床应用的监管,开展经常性监督检查。

扩展资料:

罚则

第三十二条 违反本办法有关规定,未经批准擅自设置和开办脐带血造血干细胞库,非法采集、提供脐带血的,由省级人民政府卫生行政部门予以取缔。

没收擅自开办脐带血造血干细胞库的违法所得和设备、器材以及采集的脐带血,并处以3万元以下的罚款;构成犯罪的,依法追究刑事责任。

第三十三条 脐带血造血干细胞库在提供造血干细胞过程中发生的由于质量、病原污染等差错所引起的医疗事故,由脐带血造血干细胞库承担应负的法律责任。

第三十四条 对违反本办法有关规定,或者专家委员会考评和脐带血检定机构监测结果不合格的脐带血造血干细胞库,由国务院卫生行政部门视情节予以警告,责令限期整顿。



英文翻译对照,仅供参考

Dry cell is saved illegimate. One, according to Ministry of Public Health " library of dry cell of umbilical blood hematopoiesis runs way (try out) " regulation, the setting of dry cell library examines and approve umbilical blood hematopoiesis to be in charge of by Ministry of Public Health, without approval of Ministry of Public Health, any orgnaizations are uniform must not begin umbilical blood hematopoiesis to do a cell to collect the job.

Begin umbilical blood hematopoiesis to do cellular research, must implement the concerned provision of scientific research management and clinical trial research strictly, any orgnaizations must not be violated for the purpose with scientific research compasses collect umbilical blood hematopoiesis to do a cell to reach violate compasses manage. 2, technology of cure of dry cell of umbilical blood hematopoiesis belongs to technology of the 3rd kind of medical treatment, medical establishment is approved without examine and verify, uniform must not begin clinical applying. Develop this technology permissibly the medical establishment that clinical applying must carry out print and distribute of Ministry of Public Health strictly " management of technology of cure of dry cell of umbilical blood hematopoiesis is normative (try out) " wait for normative sex file.

this cure technology clinical application is controlled strictly treating range of haemal system disease, can accept only have hold the umbilical blood that the umbilical a blood bank of licence of course of study offers. Any medical establishment do not get assistance to not have hold the orgnaization of licence of course of study collects umbilical blood. 3, each medical establishment must be carried out strictly " medical treatment advertisement runs way " regulation, in obtain " medical treatment advertisement examines a proof " hind, according to " medical treatment advertisement examines a proof " the appearance of advertisement finished product of approve content and media category release medical treatment advertisement.

Various and wholesome service wants advertisement of strict medical treatment to examine with management, strengthen medical treatment advertisement to monitor, strengthen actively the communication with industrial and commercial management department, harmonious, cogent strengthen dry to hematopoiesis of blood of the umbilical cord inside area under administration cell to treat a technology relevant advertising superintends strength, depend on lawfully stoutly compasses investigate break the law release action of advertising of false medical treatment. 4, various and wholesome service wants cogent fulfil obligation, strict according to " management of technology of cure of dry cell of umbilical blood hematopoiesis is normative (try out) " wait for relevant law, code and requirement of normative sex file, strengthen what do the cell is collected and clinical applying to umbilical blood hematopoiesis to superintend further, begin regular supervisory examination.

Patulous data:

Punish criterion

Thirtieth disobeys this method 2 times to concern a provision, without approving setting of do sth without authorization and open umbilical cord hematic hematopoiesis does cellular library, collect illegally, those who offer umbilical blood, by sanitation of provincial people government service is given ban.

The illegal earning that confiscates hematopoiesis of blood of umbilical cord of open of do sth without authorization to do cellular library and equipment, equipment and collection umbilical blood, be in with 30 thousand yuan of the following amerce; Make crime, investigate criminal duty lawfully.

Library of dry cell of hematopoiesis of 3 umbilical blood is offerring thirtieth hematopoiesis happens in dry cell process the unskillful and faulty medical or surgical treatment that because quality, cause of disease pollutes equal difference fault,causes, by umbilical blood hematopoiesis dry cell library assumes the legal responsibility that should bear.

Thirtieth concerns a provision 4 times to offending this idea, or the umbilical blood hematopoiesis with the unqualified result of test of committee of experts and orgnaization of umbilical blood calibrating that monitor does cellular library, by sanitation of the State Council service inspects a clue to give warning, instruct deadline to rectify.


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