New China Clinical Trials with HGR Filing in Feb

2020-03-06

On February 26, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from February 4, 2020 to February 17, 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/9202

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New Clinical Trial Projects with Human Genetic Resources Filing

No.	Filing Number	Project Name	Leading site	Sponsor	Filing Date
1	2020BAL0071	Clinical Evaluation of Osteocalcin Specific ELISA Kit (magneto particle chemiluminescence Method)	The First Hospital of Jiaxing	Epitope Biotechnology Co., Ltd.	2020.02
2	2020BAL0072	Clinical Evaluation of Pepsinogen I Assay Kit (magneto particle chemiluminescence Method)	The First Hospital of Jiaxing	Epitope Biotechnology Co., Ltd.	2020.02
3	2020BAL0073	Clinical Evaluation of Pepsinogen Ⅱ Assay Kit (Magnetoparticle Chemiluminescence Method)	The First Hospital of Jiaxing	Epitope Biotechnology Co., Ltd.	2020.02
4	2020BAL0074	Randomized controlled open clinical trial of fully automatic afterburner	Nanfang Hospital	Shenzhen Kaifa Technology Co.,Ltd	2020.02
5	2020BAL0075	Tolerance and pharmacokinetic clinical phase I trial of TQB3455 tablets in patients with advanced cancer	Chongqing Cancer Hospital	CTTQ	2020.02
6	2020BAL0077	“Sample Collection CIM RD004921 for verification and establishment of several Roche product reference ranges” and “CIM RD004943 for performance assessment and establishment of several Roche product reference ranges in China”	The Second Affiliated Hospital of Soochow University	Roche Diagnostics GmbH	2020.02
7	2020BAL0078	NEOPLASTINE(r) CI PLUS	Taiyuan Control Hospital	Stago	2020.02