Technical Review Points for Registration of New Coronavirus Nucleic Acid Detection Reagents(COVID-19)

On February 12^th, 2020, the CMDE issued the announcement on the Release of "Technical Review Points for Registration of New Coronavirus Nucleic Acid Detection Reagents in 2019" (No. 4 of 2020).

In order to respond to the pneumonia epidemic of new coronavirus infection, in accordance with the principles of “unity of command, early intervention, immediate review, scientific approval” and the requirements to ensure product safety, effectiveness, and controllable quality, the CMDE formulated the "Technical Review Points for Registration of New Coronavirus Nucleic Acid Detection Reagents in 2019".

Technical Review Points for Registration of New Coronavirus Nucleic Acid Detection Reagents in 2019.doc