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SFDA launches the emergency approval of A (H1N1) flu vaccines
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According to Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration, the State Food and Drug Administration (SFDA) launched the emergency approval of A H1N1 flu vaccines recently. The emergency approval will abide by the principle of early intervention, efficiency, scientific approval, being true to facts, command unity, and co-ordination.
In order to ensure the safety and effectiveness of A (H1N1) flu vaccine, SFDA requires the approval work reaching synchronization. The synchronization includes application and scene examination, production and strain file, products self-examination and batch issue application. At the same time, SFDA extends the review experts team for ensuring the legal and scientific special review and approval.
SFDA encourages flu vaccine manufacturers studying and producing A (H1N1) flu vaccines. In case of emergency, SFDA establishes the linkage mechanism，organizes and coordinates other vaccine manufacturers to co-produce flu vaccines.
For the sake of monitoring the vaccine safety and effectiveness, controlling A (H1N1) flu better, SFDA requires the regulatory departments, manufacturers, and medical institutions taking on their own responsibilities after the vaccines are approved. | |
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