SFDA: accelerate the approval and listing of self testing products of COVID-19 therapeutic drugs and antigen detection reagents

2022-03-16

On March 15, the State Food and Drug Administration held a party group (expanded) meeting, which pointed out that the government work report specifically stressed the need to "strengthen the quality and safety supervision of drugs and vaccines", solidly implement the key tasks involving drug regulatory departments, refine the timetable, road map and priorities, strengthen supervision and supervision, and ensure that they are implemented on time and quality. The meeting called for adhering to the overall planning of safety and development, epidemic prevention and control and daily supervision, and transforming the spirit of the two sessions into the effectiveness of drug regulatory reform and development. First, we should carry out in-depth special rectification actions on drug safety, strictly investigate and punish serious violations of laws and regulations according to law, comprehensively investigate and resolve potential drug safety hazards, improve drug supervision laws and regulations, and create a good drug safety environment for the 20th National Congress of the Communist Party of China. Two, we must continue to ensure the quality and supply of COVID-19 vaccine, accelerate the approval and listing of self testing products of COVID-19 treatment drugs and COVID-19 antigen detection reagents, strengthen the quality supervision of epidemic prevention products, do a solid job in internal control and prevention, and fully serve the overall situation of epidemic prevention and control. Third, we should implement the requirements of "six stabilities" and "six guarantees", deepen drug regulatory reform, optimize and improve government services, create an efficient and transparent regulatory environment, and better stimulate the innovation vitality and development power of the pharmaceutical industry. (outlook new era)

Edit:Yuanqi Tang    Responsible editor:Xiao Yu

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