Carry out to carry out " medical apparatus and instruments monitors regulation " , fulfil general office of general office of Central Committee of Communist Party of China, the State Council " the opinion that examines and approve system reform to encourage medical apparatus and instruments of medicines and chemical reagents to innovate about deepening careful to judge " (hall word 〔 2017 〕 42) , strengthen medical apparatus and instruments clinical trial controls government, supervisory management board of national medicines and chemical reagents was begun at was being organized in December 2018 the 2nd batch of medical apparatus and instruments registered application project 2018 clinical trial is supervised selective examination the job.
Decide examination result, processing now and be as follows about requirement announcement:
One
Check a result
(one) the circumstance of existence authenticity problem
1. Beijing grand of limited company of Jiang Furui technology in infra-red 1550 laser lattice treats appearance (accept order: CQZ1700097) in the clinical trial that in the the Chinese People's Liberation Army the 254th hospital begins, did not register by medical apparatus and instruments the requirement contrasts to develop a test randomly in declaring referred clinical trial plan. The test data that the clinical trial data that registers application to refer and clinical trial orgnaization save is abhorrent.
The one-time use ache of limited company of medical apparatus and instruments of 2. Jiangsu an ancient name for China treats a bag (accept order: CQZ1700482) in the clinical trial that in Zhengzhou university the 2nd accessary hospital begins, 17 suffer the person that try to enter team time by antedate instead of time of ethical committee approval is later than ethical committee to approve time, clinical trial data cannot trace to the source.
(2) the condition that existence violates other and clinical trial to concern a provision
The one-time use ache of limited company of medical apparatus and instruments of 1. Jiangsu an ancient name for China treats a bag (accept order: CQZ1700482) in Zhengzhou university the 2nd accessary hospital begins clinical trial during, the 2nd accessary hospital does not have Zhengzhou university medical apparatus and instruments is clinical experiment orgnaization aptitude.
2.The material of biology bone rehabilitate of Inc. of science and technology of coronal Hao biology (accept order: CQZ1700591) in the clinical trial that in hospital of bonesetting of Henan province Luoyang and the Changsha City the 3rd hospital begins, time of approval of committee of ethics of orgnaization of two clinical trials reachs first case of illness to choose time to antedate medical apparatus and instruments is registered examine the part of the report detects project time.
(3) the case that existence closes compasses sex issue
Check discovery this add up to compasses sex problem to basically behave in:
Did not offer " medical apparatus and instruments is clinical the experiment puts on record watch " ;
Know the inside story agrees with bookmark arrange non-standard;
Did not have something made to order by plan of clinical trial program choose an examination;
Index of main curative effect is followed visit the time window that exceeds regulation of clinical trial program;
Leakage records undesirable incident and serious and undesirable event;
Suffer those who try a product to carry, have sex and store the record is not complete etc.
2
Handle a decision
(one) Beijing grand of limited company of Jiang Furui technology in infra-red 1550 laser lattice treats appearance (accept order: CQZ1700097) treat a bag with the one-time use ache of limited company of medical apparatus and instruments of Jiangsu an ancient name for China (accept order: CQZ1700482) two clinical trials that register application project are disobeyed " clinical trial quality manages medical apparatus and instruments standard " , basis " administration of People's Republic of China allows a law " mix the 78th times " medical apparatus and instruments registers administrative measure " thirtieth sets 9 times, right afore-mentioned two register application project to make the decision that does not grant to register, since the day that does not grant to register oneself do not grant to be accepted again inside a year. Enjoin Beijing medicines and chemical reagents supervises management board and Jiangsu province medicines and chemical reagents to supervise management board to be opposite respectively two enterprises are handled according to relevant provision, supervise management board report to handle a result to national medicines and chemical reagents.
(2) enjoin Henan saves medicines and chemical reagents to control management board to Zhengzhou university the 2nd accessary hospital is handled according to relevant provision, case accuses department of relevant and wholesome administration to supervise management board report to handle a result to national medicines and chemical reagents. The problem case that clinical trial exists accuses the medical apparatus and instruments that the the Chinese People's Liberation Army the 254th hospital begins health bureau of ministry of safeguard of logistics of the Central Military Commission central.
(3) the material of biology bone rehabilitate of Inc. of science and technology of Guan Hao biology (accept order: CQZ1700591) the clinical trial that registers application project is disobeyed " clinical trial quality manages medical apparatus and instruments standard " , basis " medical apparatus and instruments registers administrative measure " thirtieth sets 9 times, make the decision that does not grant to register.
(4) apply an item to putting what closing compasses sex issue to register, supervisory management board of national medicines and chemical reagents registers union declare data and clinical trial to supervise examination circumstance to undertake integration analysis, begin careful evaluation to approve according to relevant provision.
3
About the requirement
(one) supervisory management board of each province medicines and chemical reagents should take medical apparatus and instruments seriously highly clinical trial controls administrative job, take effective measures, strengthen clinical trial orgnaization and pair of superintendency of the person that apply inside this area under administration, cogent fulfil safety of medicines and chemical reagents " 4 the most severe " requirement.
(2) the issue that orgnaization of the person that clinical trial applies medical apparatus and instruments, clinical trial and ethical committee want pair of presence undertakes be rectifyinged and reform actively, carry out strictly " clinical trial quality manages medical apparatus and instruments standard " wait for relevant requirement, make sure standard of science of clinical trial process, result is true and reliable, cogent safeguard suffers the legitimate rights and interests of the person that try.
Origin / national medicines and chemical reagents supervises management board website
Engineer as a whole: Liu Shuang
