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1、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 Administrati
2、on (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 Foodand Drug Administration Chapter 1 General ProvisionsArticle 1
3、 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 Peoples Republic of China, Law of the Peoples Republic
4、 of China on the Prevention and Treatment of Infectious Diseases, Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China, Regulations on Preparedness for and Response to Emergent Public Health Hazards, and other relevant laws and regulations.Article 2 The spec
5、ial 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, expeditious
6、ness and efficiency, and scientific review and approval, in an effort to approve drugs for the prevention and treatment of public health emergencies as soon as possible under the threat or after the occurrence of public heath emergencies.Article 3 The State Food and Drug Administration may, accordin
7、g to law, decide to follow the Procedure to conduct special review and approval of drugs for public health emergencies in any of the following circumstances:(1)Where the President of the Peoples Republic of China declares a state of emergency or the State Council decides that certain areas within a
8、province, autonomous region or municipality directly under the Central Government are in a state of emergency;(2)Where the contingency program for public health emergencies is initiated according to law;(3)Where the drug reserve department or the health administrative department of the State Council
9、 proposes a special review and approval for drugs having existing national drug standard;(4)Other circumstances applicable to special review and approval.Article 4 The State Food and Drug Administration is responsible for the review and approval of clinical trials, production and importation of drug
10、s for the prevention and treatment of public health emergencies.The (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, be responsible for on-site inspection a
11、nd sampling of the pilot products of the drugs for the prevention and treatment of public health emergencies. Chapter 2 Application Acceptance and On-site InspectionArticle 5 Where the special review and approval procedure for drug registration is initiated, the State Food and Drug Administration is
12、 responsible for the acceptance of registration applications for drugs for public health emergencies.Where a drug or a preventive biological product for public health emergencies has not been marketed in China, the applicant shall, before submission of the registration application, provide the State
13、 Food and Drug Administration with relevant research and development information.Article 6 The applicant shall submit a registration application with relevant technical dossier to the State Food and Drug Administration according to the relevant provisions and requirements on administration of drug r
14、egistration.The registration application for drug for public health emergencies may be submitted in electronic form.Article 7 Before submitting an application for registration, the applicant may provide a feasibility assessment application with general information and relevant explanations. The State Food and Drug Administration shall only comment on the scientific rationality and feasibility of the drug project, and respond within 24 hours.The response to a feasibility assessment application shall be neither deemed as the review
