New China Clinical Trials with HGR Filing
On June 24, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from May 26, 2020 to June 8, 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/9304
If you want to know more about your device category, clinical pathways, predicate information and other related to your China business, please do not hesitate to contact us info@chinameddevice.cn.
New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0292 | Official bioequivalence test for Tenofovir Alafenamide Fumarate Tablets (25 mg) in healthy subjects with randomised, open, tri-cycle, tri-cross, and partially repeated single post-meal status | The First Affiliated Hospital of Shantou University Medical College | Simcere | 2020.06 |
| 2 | 2020BAL0293 | Clinical trial of hard contact lens lubricant | The Affiliated Eye Hospital of Wenzhou Medical University | Eyebright | 2020.06 |
| 3 | 2020BAL0294 | Pancreatic Amylase Reagents (IFCC) | Zhejiang Provincial Hospital of Chinese Medicine | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.06 |
| 4 | 2020BAL0295 | Testosterone assay kit (Chemiluminescence) | Xuzhou Central Hospital | Siemens Healthineers (Shanghai) | 2020.06 |
| 5 | 2020BAL0295 | Prospective, multicenter, randomized, controlled clinical trial to evaluate the efficacy and safety of drug-coated balloon catheters in the treatment of coronary bifurcation lesions | Zhongshan Hospital | Mitrassist (Shanghai) | 2020.06 |
