State Drug Administration: has built a vaccine information traceability system to basically achieve the full traceability management of the listed vaccine

Vaccines are an important weapon in the fight against epidemics, but their safety and effectiveness are always number one, according to China Voice News Evening Peak, the state broadcaster.
Wang Tao, deputy director of the Drug Review Center of the State Drug Administration, said in an interview with CCTV on the 9th that the State Drug Administration adheres to the legal procedures, adheres to the safety bottom line, adopts a series of methods such as research linkage, rolling review and so on to improve work efficiency and ensure the safety, effectiveness and reliability of the new crown vaccine on the market with conditions.
Wang Tao introduced, the State Drug Administration took the initiative to contact the research and development team, research linkage, rolling review, take the review, verification, inspection and implementation of a series of methods, improve work efficiency.
"Up to now, the State Drug Administration has held more than 5,500 discussions, consultations and research meetings with research and development teams and expert teams in the field of vaccine drug research and development, and has approved 14 vaccines for clinical trials, five of which are in Phase III.
,2020, on the basis of the research materials submitted on a rolling basis in the previous period, The State Drug Administration's Drug Review Center formally submitted an application for registration with conditions for listing.
After acceptance, on the basis of the preliminary rolling review, the research data and data submitted by the applicant on safety, effectiveness and quality controllability were reviewed, and the verification and inspection results of the audit and inspection center of the State Drug Administration were combined, as well as the standard review and test results of the China Pharmaceutical Biologics Inspection Research Institute.
Wang Tao introduced: "After a series of strict review, review, verification, testing and data analysis in accordance with the procedures, the State Drug Administration concluded that the vaccine protection data from the mid-phase analysis of Phase III. clinical trials submitted by the applicant was 79.34 percent, meeting the pre-set conditional listing standards.
the new coronavirus inactivated vaccine from China National Pharmaceutical Company in Beijing has greater known and potential benefits than known and potential risks, meeting the criteria for conditional approval for listing.
regulatory measures to ensure the quality and safety of vaccines after the "vaccine is eligible" for market? Conditional listing in the regulatory aspects should also be more stringent, more standardized? In this regard, Chen Zhifei, deputy director of the State Drug Administration, in the previous State Council joint prevention and control mechanism press conference, in the vaccine design stage, the State Drug Administration on the active deployment and guidance of the State Drug Administration's direct technical institutions and provincial drug regulatory departments, take the initiative to carry out tracking services, forward guidance, in the workshop construction phase on the seamless interface with enterprises, the selection of capable technical personnel to guide the enterprise on-site.
Chen said:
"In the procedures do not reduce, the standard does not reduce the premise, timely to meet the requirements of the standard conditions of vaccine manufacturers issued drug production licenses."
ensure that vaccine manufacturers have technical conditions and management capabilities through strict conditions for the issuance of drug production licences.
" Chen Said that in the production supervision process, the State Drug Administration in accordance with the vaccine management law and drug management law and other relevant laws and regulations and standards requirements, with the provincial drug regulatory authorities to strengthen the quality supervision of the new coronavirus vaccine, assigned to the commissioner into the enterprise, vaccine products to carry out spot checks from time to time.
he introduced: "To the Chinese medicine Chinese medicine company beijing sent strong business capacity of professionals, resident enterprises to carry out monitoring activities to ensure that the process of vaccine production compliance, to ensure that vaccine products qualified."
the National Vaccine Inspection Center conducts regular inspections of vaccine manufacturers and conducts spot checks on vaccine products from time to time.
The National Drug Evaluation Center, in cooperation with the health department, has done a good job in monitoring suspected vaccination abnormal reactions.
" Chen Shipyon introduced, the factory's new crown vaccine must also be approved by the drug regulatory authorities, the State Drug Administration has now granted Beijing and Hubei Province drug regulatory and testing agencies to undertake the new crown vaccine approval work, each batch of vaccines to implement strict data audit and laboratory testing, to ensure that each vaccine is qualified.
, we have also strengthened the whole chain of vaccine regulation.
the State Drug Administration and the National Health and Safety Commission, has built a vaccine information traceability system, basically realized the full traceability of the listed vaccine management.
, domestic vaccine manufacturers and imported vaccines through self-built traceability systems or third-party platforms to implement full traceability.
," Chen said.
Wang Yiqun Source: CCTV Copyright Notice: All text, images and audio and video materials that indicate "Source: Mets Medicine" or "Source: MedSci Originals" are owned by Metz Medical and are not authorized, and no media, website or individual may reproduce them, and shall indicate "Source: Mets Medicine" when authorizing reprints.
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