On November 23, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from September 7, 2020 to October 29, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction. more…
On November 26, 2020, CMDE issued a notification that the “Hepatitis B Virus (HBV) Nucleic acid Quantitative Detection Kit (PCR-Fluorescence method)” of Suzhou Tianlong Bio-technology Co.,Ltd. is proposed to obtain the priority pathway approval because it is listed in the national science more…
On November 25, 2020, CMDE announced its preparation of Technical Guidelines for Overseas Clinical Trial Data Application on IVD (Draft). The overseas clinical data claiming in the guidelines refers to the research data generated during clinical trials of in vitro diagnostic (IVD) more…
NMPA (CFDA) issued the “Technical Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Trial Implementation)” (No. 77 of 2020) on US Thanksgiving Day, November 26th, 2020. The first draft for feedback on more…
On October 28, 2020, NMPA granted Innovative Approval to Peripheral Nerve Repair Graft Product produced by Jiangsu Yitong Biotechnology Co. LTD. The composition of the product is a pioneer at home and abroad; The catheter part plays the role of bridge, more…
