【正文】 the investigational drug and ensure the investigational drug is only used by the subjects of the study and the dosage and usage of the drug are in accordance to the clinical study protocol. The investigators shall not give the drug to any person not participating in the clinical study. The investigational drug shall not be sold.Article 46: A foreign applicant who wants to conduct an international multi–center clinical study shall apply at SFDA in accordance with the following provisions:The drug used for an international multi–center clinical study shall be one already registered in a foreign country or in phase II or phase III clinical trials. An application for an international multi–center clinical study of new preventive vaccine from a foreign applicant still not registered outside China shall not be accepted. In approving an international multi–center clinical study in China, SFDA may first request the applicant to firstly conduct the Phase I clinical trials in China, if needed.During a study conducted in China, the Applicant shall, in accordance with the relevant regulations, report to SFDA any serious adverse events or unexpected adverse events which occur in any countries.Upon the pletion of the study, the Applicant shall submit the plete clinical study report to SFDA.Data generated from an international multi–center clinical trial used for drug registration in China, shall be in accordance with the relevant provision of this Regulation, and the applicant shall submit the plete research information of the study.Chapter 5: Application and Approval of New DrugsSection 1: Basic RequirementsArticle 47: The application dossier submitted for new drug registration shall be plete and standardized with authentic and reliable data. In citing literature and materials, the name of the work(s) and journal(s) as well as volume, issue and page number shall be provided. For unpublished literature and materials, an authorization letter from the owner must be provided. For any foreign language materials a Chinese translation should be provided in accordance with relevant requirements.Article 48: SFDA may use fast track approval process for the following new drug:New active ingredients and its preparation extracted from TCM, natural drugs, or preparation made of material from plant, animal and minerals, which have not been marketed in China and。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。new antiviral drug for AIDS and drug used for diagnosis and prevention of AIDS, cancer and orphan drug。quality problems in the drug used for clinical trials。 the safety of the subjects cannot be effectively ensured。 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