State Food and Drug Administration: 24 new coronavirus vaccines have been approved for clinical trials.
Release time:
2021-09-07
Chen Shifei, deputy director of the State Drug Administration, said on the 6th that the State Drug Administration has approved 24 new coronavirus vaccines into clinical trials, of which four new coronavirus vaccines have been approved for listing with conditions.
On the 6th, the State Council Information Office held a press conference on "stimulating market vitality, standardizing market order and helping build a well-off society in an all-round way.
A reporter asked: At present, China's domestic 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 the new coronavirus vaccine? What has been done to ensure the quality and safety of the new coronavirus vaccine after its launch?
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 listing of vaccines as the top priority of epidemic prevention work. A series of working measures have been taken:
The first is to formulate guidelines in a timely manner, preset standards, always put the safety and effectiveness of vaccines in the first place, coordinate with WHO and other international drug regulatory agencies, formulate technical guidelines in a timely manner, and set safety and effectiveness of the new crown vaccine. The technical standards also provide a 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.
Second, the research and review linkage, rolling review and approval, accelerate the development of the new crown vaccine market. The State Food and Drug Administration has organized a team of experts to promote vaccine research and development in conjunction with research units. At the same time, the implementation of rolling submission of research materials, rolling review and approval, simultaneous inspection and inspection work, accelerate the speed of the new crown vaccine market. Twenty-four new coronavirus vaccines have been approved for clinical trials, of which four new coronavirus vaccines have been approved for marketing with conditions.
Third, actively participate in international cooperation, China has two new coronavirus vaccines have been included in the World Health Organization emergency use list.
Chen Shifei said that in terms of post-marketing supervision of vaccines, multiple measures should be taken to ensure the quality and supply of vaccines:
First, to carry out inspections, the new crown virus vaccine production enterprises to carry out full coverage of the inspection and inspection, timely detection of problems, timely supervision and rectification, to ensure that the quality management of vaccine production can continue to meet the requirements of the specification;
The second is to carry out on-site supervision and service. 77 inspectors have been stationed at the production sites of 14 new crown virus vaccines across the country to carry out follow-up inspection of the whole production process, close to service and supervision, supervise and guide production enterprises to organize production in strict accordance with GMP standards, coordinate and solve various difficulties encountered by enterprises in production in a timely manner, and ensure continuous and stable vaccine production;
Third, batch by batch to do a good job of quality inspection, strict control, so far has completed the inspection and batch issued more than 8000 batches, a total of 3 billion doses, the new crown vaccine all in line with the provisions, a strong guarantee of vaccine vaccination needs;
The fourth is to strengthen the monitoring and disposal of abnormal reactions to vaccination, 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, we will ensure that every new coronavirus vaccine vaccinated by the people is qualified and safe.
Source: China News Network
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