Home> News

NMPA approves four nucleic acid reagent test kits for novel coronavirus

Updated: 2020-01-26

     

The National Medical Products Administration (NMPA) recently approved four 2019-nCoV testing products developed by four enterprises to further improve the supply of nucleic acid detection reagents and meet the needs of epidemic prevention and control.

After the outbreak, the NMPA immediately started emergency approval procedures of medical device to speed up review and approval in accordance with the principle of unified command, early intervention, rapid and science-based review and approval and with the requirement of ensuring product safety, effectiveness and quality.

Four products have been received emergency approval including nucleic acid reagent test kits (fluorometric PCR) and nucleic acid sequencing systems. 

Meanwhile, the NMPA required provincial medical products administrations to strengthen supervision and inspection of manufacturers of these products to ensure product quality and safety.

The NMPA will continue the special approval procedures for drug and medical devices needed for epidemic prevention and control to accelerate marketing of such products as early as possible.