The State Food and Drug Administration (SFDA) issued on November 18, 2005 special drug approval procedures, which provide an institutional support for providing drugs needed for handling unexpected public health crises. Under the new provisions, A China developed bird flu vaccine for humans has entered this special approval procedure.

According to the special drug approval procedures, 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 to prevent, control and eliminate the threats to public health and life in an effective and timely manner when unexpected public health events happen or there are potential, sudden threats to public health.

By "uniform commanding and early intervention", it means that SFDA will take charge of the acceptance of this kind of applications and become aware of the research and development of these drugs in the early stages of drug R&D and registration. Prior to the submission of the application, applicants may submit the application for the feasibility assessment of the drug.

By "fast, efficient and scientific approval", it means that SFDA will make the top priories the application acceptance, field checks, technical review, registration tests, administrative examination, follow-on monitoring after receiving drug registration applications. SFDA will set up a special expert team to assess and examine these registration applications. As for preventive biological products used to prevent and control major epidemic situation of infectious diseases, registration tests and self-examination can be conducted simultaneously to reduce the time needed for approval. For those applications changing only the prototype strains used for vaccine production, but not production processes or quality specifications, approval decision shall be made within three days after the virus strains used for producing vaccines are confirmed.

The new provisions stress that drugs specially approved for emergency prevention shall be listed as key products under monitoring, their adverse drug reaction monitoring and postmarketing surveillance shall be strengthened.

Drugs and medical devices used to prevent and treat bird flu for humans, including bird flu vaccines, shall all be included in the special approval procedure.