In order to encourage research and development of new drugs and strengthen risk control and management, the State Food and Drug Administration (SFDA) formulated Requirements on Special Approval of New Drug Registration, which was formally issued and implemented as of January 7, 2009. The Requirements follow the general principles for special approval of new drug registration, namely "early intervention, priority review, multi-channel communication, and dynamic data supplement", specifying the conditions, procedures, and requirements for special approval of new drug registration, detailing the rights and obligations of the applicants during the special approval process of new drug registration, fully displaying the characteristics of encouraging innovation and enhancing risk control and management, thus effectively promoting the research and development of China's innovative drugs.