China News Service, March 15 "It is expected that more than a dozen provincial-level inspection agencies will soon have vaccine inspection and batch issuance capabilities, and continue to adapt to and meet the needs of my country's new coronavirus vaccine batch issuance inspection." On the 15th, the National Drug Administration When answering related questions, Yuan Lin, Director of the Drug Supervision Department of the Bureau, made the same answer.
Data map: Medical staff inject vaccines for vaccinators.
Photo by China News Agency reporter Jiang Qiming
On the 15th, the State Council’s Joint Prevention and Control Mechanism held a press conference on the promotion of new crown vaccination.
At the meeting, a reporter asked whether the current batch issuance capacity of my country meets the large-scale production of new coronavirus vaccines?
"Vaccines are our focus or require strict supervision. The method of batch issuance inspection must be used as the bottom line or even the red line of vaccine quality and safety to ensure its safety." Yuan Lin said, at the same time batch issuance is also an internationally accepted method. Effective regulatory measures and powerful methods for biological products or vaccines.
The world’s first "Vaccine Management Law" officially implemented on December 1, 2019 clearly stipulates that domestic and imported vaccines marketed in my country must be subject to batch issuance management in accordance with the law. Specifically, each batch of marketed vaccines Vaccines need to be reviewed and inspected by a nationally recognized batch issuing inspection agency.
At the same time, Yuan Lin said that the State Food and Drug Administration attaches great importance to the construction of batch issuance inspection capabilities, and timely and comprehensively analyzes the current situation of vaccine production and batch issuance inspection capabilities. With the strong support and coordination of relevant national departments, the phased and step-by-step deployment has been implemented in advance. The measures taken to further increase and accelerate the capacity building of biological product batch issuance and inspection institutions.
Yuan Lin pointed out that at present, including national-level drug inspection institutions, provincial-level drug inspection institutions such as Beijing, Hubei, and Guangdong have fully equipped the ability to inspect and batch issue new coronavirus vaccines.
At the same time, it is also actively promoting the capacity building of other relevant provincial-level drug inspection agencies. It is expected that more than a dozen provincial-level inspection agencies will soon have vaccine inspection and batch issuance capabilities, and continue to adapt to and meet the needs of my country's new coronavirus vaccine batch issuance inspection.
"We are also stepping up efforts to continuously improve the quality and efficiency of inspections to match the production capacity of the new crown vaccine. We require all batch issuing agencies to strengthen management and carry out vaccine safety and effectiveness inspections in accordance with legal requirements and national standards. At the same time, It is also necessary to guarantee the quality of batch issuance and inspection work." Yuan Lin pointed out.
In order to actively cooperate with the continuous expansion of China’s new coronavirus vaccine production capacity, Yuan Lin said, “We require inspection agencies to tap potential and improve efficiency within the premise of ensuring quality. The statutory self-inspection of the new coronavirus vaccine is started, carried out simultaneously, and completed simultaneously, which greatly shortens the new coronavirus vaccine market cycle." Through the continuous strengthening of the batch issuance inspection capacity of the national drug supervision system, the inspection and batch issuance of the new coronavirus vaccine can be fully ensured. Ability, effective coordination and matching with the company’s growing production capacity and output, comprehensively guarantee the smooth development of the new coronavirus vaccination work.