China News Service, September 6, Chen Shifei, deputy director of the State Drug Administration, said on the 6th that the State Drug Administration has approved 24 new coronavirus vaccines to enter clinical trials, of which 4 new coronavirus vaccines have been approved for conditional listing.
On the 6th, the State Council Information Office held a press conference on "stimulating market vitality, standardizing market order, and building a well-off society in an all-round way".
A reporter asked: At present, China's domestically produced new coronavirus vaccine has played an important role in the global fight against the epidemic.
What measures has the State Food and Drug Administration taken to promote the development and marketing of new coronavirus vaccines?
What work has been done to ensure the quality and safety of the new coronavirus vaccine after it went on the market?
Data map: Citizens of Nanchang City, Jiangxi Province were vaccinated against the new crown vaccine at the Hongjiaozhou Campus of the Second Affiliated Hospital of Nanchang University.
Photo by China News Agency reporter Liu Lixin
Chen Shifei said that as a powerful weapon to prevent and control the epidemic, the State Food and Drug Administration attaches great importance to the development and marketing of vaccines as the top priority of the epidemic prevention work.
A series of work measures have been taken:
The first is to formulate guidelines in a timely manner, pre-set standards, and always put the safety and effectiveness of vaccines in the first place, coordinate with WHO and other international drug regulatory agencies, and formulate technical guidelines in a timely manner, setting the new crown vaccine to be safe and effective The technical standards of China also provide scientific basis for the development and evaluation of my country's new crown vaccine, and create conditions for China's vaccine to become a world public product.
The second is the linkage of research and review, rolling review, review and approval, and accelerate the development and marketing of the new crown vaccine.
The State Food and Drug Administration organized a team of experts to jointly promote vaccine research and development with research units.
At the same time, rolling submission of research materials, rolling review and approval, and simultaneous inspections and inspections have been implemented to speed up the launch of the new crown vaccine.
24 new coronavirus vaccines have been approved to enter clinical trials, of which 4 new coronavirus vaccines have been approved for conditional marketing.
The third is to actively participate in international cooperation. At present, two new coronavirus vaccines in my country have been included in the emergency use list of the World Health Organization.
Chen Shifei said that in terms of post-marketing supervision of vaccines, various measures have been taken to ensure the quality and supply of vaccines:
The first is to carry out inspections and inspections, to carry out inspections and inspections with full coverage of the new crown virus vaccine production enterprises, to find problems in time, and to supervise rectification in time to ensure that the quality management of vaccine production can continue to meet the regulatory requirements;
The second is to implement on-site supervision and service. 77 inspectors are stationed to 14 new crown virus vaccine production sites across the country to implement follow-up inspections on the entire production process, close to service and supervision, and supervise and guide production enterprises to strictly follow GMP regulations. Production, timely coordination and resolution of various difficulties encountered by enterprises in production, to ensure continuous and stable vaccine production;
The third is to carry out quality inspections batch by batch and strictly control them. So far, more than 8,000 batches of inspections and batches have been issued, with a total of 3 billion doses. All the new crown vaccines meet the regulations, which effectively guarantees the vaccination requirements of the vaccine;
The fourth is to strengthen the monitoring and handling of abnormal vaccination reactions, and cooperate with the National Health Commission and the disease control department to carry out continuous monitoring and analysis of relevant data.
Chen Shifei said that through the above-mentioned series of work measures, it is ensured that every new coronavirus vaccine vaccinated by the people is qualified and safe.