March2Xi Jinping, General Secretary of the CPC Central Committee, President of the People's Republic of China and Chairman of the Central Military Commission, visited Beijing on the prevention and control of new coronary pneumonia.

Xi Jinping came to Tsinghua University School of Medicine for investigation and research. He successively walked into the Global Health and Infectious Disease Research Center, the Beijing Laboratory of Biomedical Testing Technology and Instruments, and asked experts to learn more about the progress of innovative drug development and the development and application of new testing reagents and testing equipment, and watched the ongoing Enzyme-linked immunosorbent assay.

Xi Jinping pointed out that there are two fronts in the fight against the new coronary pneumonia epidemic, one is the front line of epidemic prevention and control, the other is scientific research and material production, the two fronts should cooperate with each other and fight side by side. Xi Jinping hopes that they will strengthen cooperation with the front, organize capable forces, handle urgent matters, and accelerate the advancement of new testing reagents, antibody drugs, vaccines, and diagnosis and treatment programs.

Xi Jinping pointed out that vaccines, as special products for healthy people, are crucial to epidemic prevention and control, and safety requirements are also the first. It is necessary to accelerate the research and development of vaccines with multiple technical routes, and at the same time closely follow the progress of foreign research and development, strengthen cooperation, and strive to promote the clinical trials and marketing of vaccines as soon as possible. It is necessary to promote the organic connection between vaccine research and development and industrialization chain, accelerate the establishment of a vaccine research and development and industrialization system with enterprises as the main body and a combination of production, education and research, establish a national vaccine reserve system, and make comprehensive preparations for possible normalized prevention and control work.

1,1Month31On the same day, the U.S. Food and Drug Administration (FDA) ApprovedAudenzlisting,Audenz(Influenza A[H5N1]Monovalent Vaccines, AdjuvantMF59) is used to prevent type A in the case of a pandemic.H5N1The first adjuvant, cell-based influenza vaccine for influenza.

2,2Month26On the same day, the U.S. Food and Drug Administration (FDA) First Adjuvant Quadrivalent Influenza Vaccine ApprovedFluad Quadrivalent(Influenza vaccine, adjuvantMF59), by AustraliaSeqirusSeasonal adjuvant quadrivalent influenza vaccine developed by the company to help65elderly people aged and above to resist seasonal influenza;

3,2Month28On the 15th, the State Food and Drug Administration publicly solicited opinions on the "Drug Records and Data Management Regulations (Draft for Solicitation of Comments)" to standardize the records and management of drug development, production, operation and use activities;

4、2Month29On the same day, the trivalent freeze-dried nasal spray influenza attenuated live vaccine developed by Changchun High-tech subsidiary was approved for drug registration, which is the first domestic influenza attenuated live vaccine administered in the form of nasal spray;

5、3Month2On the 15th, the State Food and Drug Administration publicly solicited opinions on the Inspection Procedures for Drug Marketing License Holders (Draft for Solicitation of Comments) and the Inspection Points for Drug Marketing License Holders (Draft for Solicitation of Comments). The responsibility for the safety, effectiveness and quality controllability of drugs in the whole process of drug development, production, operation and use will further standardize the inspection work of holders;