Chinanews.com, December 22. According to news from the website of the State Food and Drug Administration on the 22nd, recently, the State Food and Drug Administration has followed the requirements of the "Twenty Articles" and "New Ten Articles" of the joint prevention and control mechanism, combined with the new situation of epidemic prevention and control, the new The task requires the whole system to cooperate and optimize various measures for epidemic prevention and control, further strengthen the quality and safety supervision of epidemic prevention and control drugs, and ensure the overall stability of the drug safety situation.
The first is to strengthen emergency review and approval.
Adhere to the linkage of research and review, and start the emergency approval process in accordance with laws and regulations. As of now, 5 new coronavirus vaccines have been approved with conditions, and another 8 new coronavirus vaccines have been included in emergency use; 11 therapeutic drugs and 128 various testing reagents have been approved.
For those already on the market but need to expand the supply, drug regulatory departments at all levels have adopted various measures to promote the rapid increase of production and capacity expansion of enterprises.
At the same time, a joint document was issued with relevant departments, requiring provincial food and drug administrations to implement rapid approval for applications for the dispensation and use of hospital preparations for children. Some effective hospital preparations can serve patients in a wider range faster.
The second is to strengthen the supervision of drug production and circulation.
Pharmaceutical companies are required to tighten the string of quality and safety at all times, and deploy drug regulatory departments at all levels to increase supervision and inspection and quality sampling inspections.
In production, strictly control raw materials, process and release.
In circulation, strictly control the key links such as purchase channels, cold chain guarantee, storage and transportation management.
At the same time, strengthen the monitoring of online sales of drugs and standardize online sales.
The third is to strictly investigate violations of laws and regulations.
Strengthen all-round supervision online and offline, resolutely take risk control measures for those with hidden risks; resolutely file and investigate those who have violated laws and regulations; resolutely transfer those suspected of crimes to the public security organs for criminal responsibility.
Those who dare to take risks during the epidemic prevention period will be severely punished with a clear attitude.
(China New Finance and Economics)