【正文】 evidence that the investigative drug is not effective。 the drug safety evaluation shall be conducted in accordance with Good Laboratory Practice for PreClinical Laboratory Studies (GLP). Article 17: Institutions engaged in drug research and development shall have the necessary personnel, facility, equipment, instruments, conditions and management system needed corresponding to the research project. The animals, reagents and raw materials used for experiments shall ply with relevant national regulations and requirements. The authenticity of all data and materials shall be ensured.Article 18: When an application is only made for registration of preparation, the raw materials of the investigative drug substance used for this preparation shall have a Drug Approval Number, Import Drug Certificate or Pharmaceutical Product Certificate, and the raw materials shall have been obtained from legal channels. Relevant certified documents should be provided if the drug substances registered by other party or still pending the approval process have been used. Any investigative drug substance which does not have a Drug Approval Number, Import Drug Certificate or Pharmaceutical Product Certificate shall go through SFDA approval process.Article 19: If an applicant authorizes another institution to conduct the study of drugs, or any single experiment, inspection or pilot production and manufacture, the applicant shall sign a contract with the authorized party and maintain responsibility for the authenticity of study data.Article 20: If an applicant uses the preclinical study documents from a foreign drug research institution as supporting materials for a drug registration application, an explanation for the items referencing the page numbers shall be provided by the institution and notarized certificate of the institution39。s drug application review process, except for new information related to the innovative drug ingredients or drug safety, or the supplemental information required by SFDA, the applicant shall not submit supplemental technical material to SFDA. If new technical materials must be added, the applicant shall withdraw the application, and reapply according to the original application procedures.Article 59: For those withdrawn or returned application, after further studies, if the requirements of the Regulation are met and there is no new drug of the same kind enter into monitoring period, the original applicant may resubmit the application according to original application procedures.Section 3: Approval of New Drug ProductionArticle 60: After pletion of a clinical study, the applicant shall fill out the Drug Registration Form, and submit clinical study information, changes and supplemental information, with detailed explanation and justifications, to the PDA where the applicant is located. At the same time, the applicant shall submit raw material for the preparation of the standard substance to NICPBP.Article 61: PDA shall examine for form the application dossier, and if the requirement are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, the application will not be accepted with issuing of nonacceptance notification of drug registration application, with explanation of reasons.Article 62: PDA shall, within 5 days upon acceptance of the application, organize and conduct onsite inspection for production and research of the drug, take sample drugs of 3 consecutive batches, and notify the drug control institute for inspection. Upon pletion, PDA shall, within the prescribed time limit, submit remendations and , inspection report and application dossier to SFDA, and notify the applicant..Article 63: The 3 consecutive batches of sample product used for new drug application s。s approval, SFDA shall not approve a subsequent application that used, without the express consent of the original applicant, the undisclosed Ramp。fraud in the clinical study。serious adverse event was not timely reported。s standards approved by SFDA, or authorize a drug control institute designated by Article 147 and Article 148 of this Regulation to conduct the quality test. The drug may not be used for Clinical Trails before it has passed the inspection. SFDA may designate a drug control institute to conduct a random inspection for the investigational drug.Vaccine, blood products and other bioproducts designated by SFDA as well as investigational drugs produced overseas must be inspected by a drug control institute designated by SFDA. The drug may not be used before it has passed the inspection. The applicant assumes all responsibility for the quality of the investigational drug.Article 33: Before conducting the clinical study, the applicant shall file with SFDA information such as the clinical study protocol, name of the principle investigator of the leading institution, participating institutions and investigators, approval letter from ethics mittee, and the sample of the Informed Consent Form, also providing a copy to the PDA where the institutions are located. Section 3: Administration of a Clinical StudyArticle 34: During the clinical study, the applicant shall designate inspectors to monitor the implementation of GCP.Article 35: If an applicant discovers that an institution conducting clinical study is in violation of relevant regulations, or is not following the clinical study protocol, the applicant shall try to correct the situation. For serious violation, the applicant may request to suspend or stop the clinical study and shall submit a written report to SFDA and the relevant PDA. Article 36: Upon the pletion of each phase of the clinical study, the applicant shall submit a clinical study and statistical analysis report to SFDA and relevant PDA. If the duration of clinical study exceeds 1 year, the applicant shall s