Huang Guo, deputy director of the State Food and Drug Administration, said today (December 20) at the special press conference of the State Administration for Market Regulation on price stability and quality assurance of epidemic-related drugs and medical supplies that in the near future, in accordance with the "Twenty Articles" and "New According to the requirements of the "Ten Articles", combined with the new situation and new tasks of epidemic prevention and control, the State Food and Drug Administration has carried out re-mobilization and redeployment, requiring the whole system to cooperate and optimize various measures for epidemic prevention and control, and further strengthen the quality and safety supervision of epidemic prevention and control drugs. Ensure the overall stability of the drug safety situation.
The first is to strengthen emergency review and approval to serve clinical drug needs.
In order to provide more and better "weapons" for prevention and control, the State Food and Drug Administration has launched emergency approval procedures in accordance with laws and regulations.
As of now, the State Food and Drug Administration has approved 5 new coronavirus vaccines with conditions, and another 8 new coronavirus vaccines have been included in emergency use after demonstration and approval by relevant departments; 11 therapeutic drugs and 128 various testing reagents have been approved.
In the future, we will continue to implement research and review linkage to speed up the review and approval of urgently needed drugs for clinical diagnosis and treatment of new coronary pneumonia.
For those that are already on the market but need to expand the supply, the drug regulatory authorities at all levels will adopt advanced services, speed up the approval process for changes after the drug is on the market, and allow companies to adopt various methods such as entrusted production to quickly increase production and expand capacity.
In addition, the State Food and Drug Administration jointly issued a circular with health and traditional Chinese medicine management departments, requiring provincial drug regulatory departments to implement rapid approval of applications for dispensing and using preparations prepared by medical institutions for children. In principle, it should be within 3 working days. Complete the approval.
Some hospital preparations that work well can serve patients faster and on a larger scale.
The second is to stick to the bottom line of quality and safety, and strengthen the supervision of drug production and circulation.
The State Food and Drug Administration requires the majority of pharmaceutical companies 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.
Especially for new crown virus vaccines, new crown treatment drugs, and antigen detection reagents, etc., it is necessary to consolidate the main responsibility of the enterprise and the responsibility of territorial supervision to ensure that the quality system is in place, risk prevention and control is in place, detail management is in place, and adverse reaction monitoring is in place.
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 for those who do not sell in accordance with the regulations, measures such as link removal, web page blocking, and sales restrictions must be taken as soon as possible to regulate online sales.
The third is to strictly investigate violations of laws and regulations to form a strong deterrent effect.
During the epidemic prevention period, those who dare to take risks must have a clear attitude and severely crack down.
The State Food and Drug Administration has deployed drug regulatory departments at all levels to strengthen all-round supervision online and offline, and resolutely take risk control measures for those with hidden risks; for those with violations of laws and regulations, they will be resolutely filed for investigation; for suspected crimes, they will be resolutely transferred to the public security organs pursue its criminal responsibility.
The State Food and Drug Administration requires that all localities should investigate and deal with a number of typical cases in conjunction with the ongoing special rectification of drug safety across the country, and take measures such as punishing individuals, public exposure, and joint punishment to form a strong deterrent.
(CCTV news client headquarter CCTV reporter Yu Jingying)