The Special Drug Approval Procedure of the China Food and Drug Administration (CFDA) was issued on Nov.18, 2005. It is formulated for the purpose of effectively preventing, timely controlling and eliminating the dangers of public health emergencies, and safeguarding the physical health and life safety of the general public, which includes:

Chapter I General Provisions

Chapter ll Applications,Acceptance and On-Site Verification

Chapter lll Registration Inspections 

Chapter IV Technical Review 

Chapter V Clinical Trials

Chapter VI Examination,Approval and Monitoring of Drug Production

Chapter Vll Supplementary Provisions