Procedures of the State Food and Drug Administration for Special Examination and Approval of Drugs

Procedures of the State Food and Drug Administration for Special Examination and Approval of Drugs Order of the State Food and Drug Administration (No. 21) The “Procedures of the State Food and Drug Administration for Special Examination and Approval of Drugs”, which were deliberated and adopted at the working meeting of the State Food and Drug Administration on November 18, 2005, are hereby promulgated, and shall come into force on the date of promulgation. Director General Shao Mingli November 18, 2005 Procedures of the State Food and Drug Administration for Special Examination and Approval of Drugs Chapter I General Provisions Article 1 The present Procedures are formulated in accordance with the “ Law of the People's Republic of China on Drug Administration ”, the “ Law of the People's Republic of China on Prevention and Treatment of Infectious Diseases ”, the “ Regulation for the Implementation of the Law of the People's Republic of China on Drug Administration ”, the “ Regulation on Responding to Public Health Emergencies ” and other relevant laws and regulations 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. Article 2 The procedures for special examination and approval of drugs shall refer to the procedures and requirements for special examination and approval of drugs needed in responding to the public health emergency whose threat is existing or which has occurred, which is conducted by the State Food and Drug Administration in compliance with the principles of unified command, intervention at the early stage, high efficiency and rational approval, so that the prophylaxis drugs needed in responding to the public health emergency can be approved as soon as possible. Article 3 Where any of the following circumstances arises, the State Food and Drug Administration may legally decide to follow the present Procedures to conduct special examination and approval on the prophylaxis drugs needed in responding to a public health emergency: (1) The president of the People's Republic of China announces the emergent state, or the State Council decides partial areas within a province, autonomous region, or municipality directly under the Central Government to be under the emergent state; (2) The procedures for responding to the public health emergency are started up in accordance with the law; (3) The pharmaceutical reserve department or the health administrative department of the State Council proposes to conduct special examination and approval of drugs for which there have already been national standards; (4) Other circumstances under which the special examination and approval is needed. Article 4 The State Food and Drug Administration shall take charge of examining and approving clinical trials, manufacture and import, etc. of the prophylaxis drugs needed in responding to public health emergencies. The (food) drug administrative department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, take charge of making on-site checks of the prophylaxis drugs needed in responding to public health emergencies, and of drawing trial samples, as well. Chapter II Applications, Acceptance and On-site Checks Article 5 After the procedures for special examination and approval of drugs are started, the applications for registration of prophylaxis drugs needed in responding to public health emergencies shall be uniformly accepted by the State Food and Drug Administration. Where a drug needed in responding to a public health emergency or a preventive biological product is not sold on the domestic market, the applicant shall, before filing the application for registration, inform the State Food and Drug Administration of the relevant information on research and development thereof. Article 6 An applicant shall, pursuant to the relevant provisions and requirements on administration of drug registration, file an application for registration to the State Food and Drug Administration, and submit the relevant technical documents. The application for registration of a prophylaxis drug needed in responding to public health emergencies may be filed in an electronic method. Article 7 An applicant may, before submitting an application for registration, file the application for pharmaceutical feasibility assessment first, and submit the comprehensive information and relevant explanations. The State Food and Drug Administration shall only deliberate the scientificity and feasibility of project initiation of the declared pharmaceutical, and shall make a reply within 24 hours. The reply to an application for pharmaceutical feasibility assessment shall not be deemed as the examination and approval opinions, and shall not have leg......