SFDA-特殊审批管理办法英文版.docx

Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration(SFDA Decree No. 21)The Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration, adopted at the executive meeting of the State Food and Drug Administration (SFDA) on November 18, 2005, is hereby promulgated and shall go into effect as of the date of promulgation.?????????????????????????????????????????????????????????????????????????????????????????????? Shao Mingli?????????????????????????????????????????????????????????????????????????????????????????????? Commissioner of SFDA?????????????????????????????????????????????????????????????????????????????????????????????? November 18, 2005???????? Special Review and Approval Procedure for Drug Registration of the State Food?and??????????????????????????????????????????????????????????? Drug Administration??????????????????????????????????????????????????? Chapter 1??? General ProvisionsArticle 1??? This Procedure is formulated for the purpose of effective prevention, timely control and elimination of the hazards of public health emergencies to ensure the health and safety of the public in accordance with the Drug Administration Law of the People’s Republic of China, Law of the People’s Republic of China on the Prevention and Treatment of Infectious Diseases, Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, Regulations on Preparedness for and Response to Emergent Public Health Hazards, and other relevant laws and regulations.Article 2??? The special review and approval procedure for drug registration refers to the procedure and requirements of the State Food and Drug Administration to carry out special review and approval of drugs for handling public heath emergencies under the principle of unified leadership, early involvement, expeditiousness and efficiency, and scientific review and approval, in an effort to approve drugs