New China Clinical Trials with HGR Filing

2020-05-27

On May 20, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from April 28, 2020 to May 11, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction.

Link: http://www.cncbd.org.cn/Notice/Detail/9266

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New Clinical Trial Projects with Human Genetic Resources Filing

No.	Filing Number	Project Name	Leading site	Sponsor	Filing Date
1	2020BAL0281	Clinical trial of GT2000 multi-parameter health testing machine for pulse oxygen saturation	Wuhan Asia Heart Hospital	GareaTech	2020.05
2	2020BAL0282	Clinical verification of safety and effectiveness of ultrasonic cutting hemostatic knife system	Beijing Ditan Hospital, Capital Medical University	B.J.Zh.F.Panther Medical Equipment Co., Ltd.	2020.05
3	2020BAL0285	A multicenter, randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of aerosol inhalation of formoterol fumarate inhaled solution in the treatment of adult chronic obstructive pulmonary disease	The First Affiliate Hospital of Guangzhou Medical University	Joincare Pharmaceutical Group Industry Co.,Ltd	2020.05
4	2020BAL0286	Phase I clinical study on the synthesis of haemophilus influenzae type b conjugate vaccine	GuangXi Center for Disease Prevention and Control	Changchun Heber Biological Technology Co.,Ltd.	2020.05
5	2020BAL0283	Bioequivalence test of tizanidine hydrochloride tablets on fasting and postprandial conditions in human body	Yiyang Central Hospital	Creditpharma	2020.05
6	2020BAL0288	Efficacy and safety of the Embolectomy Device System in the treatment of acute ischemic stroke	Xuanwu Hospital, Capital Medical University	TJWY Medical	2020.05