State Drug Administration: Strengthening emergency review and approval, 8 new coronavirus vaccines included in emergency use

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In accordance with the State Council joint prevention and control mechanism “twenty” and “new ten” requirements, the State Drug Administration recently combined with the new situation and new tasks of epidemic prevention and control, requiring the entire system to optimize the measures of epidemic prevention and control, to further strengthen the quality of epidemic prevention and control of drugs Safety supervision, to ensure the overall stability of the drug safety situation.

First, strengthen the emergency review and approval, adhere to the research and review linkage, in accordance with the law to start the emergency approval process, so far, has been conditionally approved five new coronavirus vaccine, another eight new coronavirus vaccine into emergency use; approved 11 therapeutic drugs, various types of testing reagents 128. For those already listed but need to expand supply, drug regulatory departments at all levels have adopted various approaches to promote rapid production and expansion of enterprises. At the same time, and the relevant departments jointly issued a document requiring the provincial drug regulatory departments to implement rapid approval of applications for the transfer of hospital preparations for children’s use, some of the management of good hospital preparations, can be faster in a wider range of services to patients.

Second, strengthen the supervision of drug production and distribution. Drug companies are required to always tighten the string of quality and safety, the deployment of drug supervision departments at all levels to increase supervision and inspection and quality sampling efforts. In the production, strict control of raw materials, process, release off. In circulation, strict control of the purchase channel, cold chain protection, storage and transportation management and other key links. At the same time, strengthen the monitoring of network sales of drugs, regulate the behavior of online sales.

At the same time, strictly investigate illegal and irregular behavior. Strengthen the all-round supervision online and offline, and resolutely take risk control measures for those with hidden risks; resolutely file and investigate those with violations; and resolutely transfer those suspected of crimes to the public security authorities to pursue their criminal responsibilities. For those who dare to take risks during the epidemic prevention period, give a severe crackdown with a clear attitude.