The State Food and Drug Administration (SFDA) initiated the special approval procedure for pandemic influenza vaccine on March 28, 2008.

Since 2003, highly pathogenic avian influenza virus (H5N1) not only has transmitted and spread among birds but also caused human cases of avian influenza. World Health Organization (WHO) has called on control action around the world against the possible influenza pandemic. One measure of preparedness for the influenza pandemic is vaccine and drug stockpiles. SFDA always gives top priority to the registration application of pandemic influenza vaccine. In view of the complexity in vaccine research and development and the urgency of the pandemic influenza prevention, SFDA tried to know about the research and development of the vaccine in the early stages of R&D and registration; communicated with applicants on the technical requirements for drug examination and approval in time; and conducted registration tests simultaneously with enterprise's self-examination to reduce the time needed for approval.

To prevent human-to-human transmission of H5N1 and ensure public health and the successful holding of the Beijing Olympic Games, in accordance with the SFDA Special Procedures for Drug Approval (SFDA Order No. 21), SFDA initiated the special approval procedure for Beijing Sinovac Biotech Co Ltd's pandemic influenza vaccine, which has completed phase II clinical trials. SFDA will organize the expert panel to complete the technical review process in the shortest possible time. After the completion of technical review, SFDA will decide whether to sign and issue the approval certification document and the approval number within 3 days.

According to the special procedures for drug approval, when unexpected public health events happen or there are potential sudden threats to public health, SFDA will include in its special approval procedures the drugs needed to solve unexpected public health crises on the basis of uniform commanding, early intervention, fast, highly efficient and scientific principles, so that drugs needed to solve unexpected public health crises can be approved as soon as possible.