Technical Guidelines for Overseas Clinical Data Application on IVD (Draft)

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) reagents to be registered in China. All the data should all or simultaneously be generated in the overseas clinical institutions that meet the requirements of the country (region) where the clinical trial is conducted.

Takeaways for difference assessment on overseas and domestic clinical trials are the clinical trial quality management requirements (including ethical requirements) and the key elements in clinical trial design.

All kinds of opinions are welcome to be filled in the information collection form and submit it to CMDE before December 15, 2020 via email.

Link: https://www.cmde.org.cn/CL0004/22036.html