【正文】 ine 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 For unpublished literature and materials, an authorization letter from the owner must be provided.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 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 submit an annual clinical study progress report to SFDA and relevant PDA from the date of the approval of the study.Article 37: A clinical study shall start within 2 years of approval. Otherwise the approval certificate shall automatically bee null and void. A reapplication shall be submitted to resume the study.Article 38: The institutions and personnel participating in the clinical study shall be familiar with the characteristics, therapeutic activities, efficacy and safety of the investigational drugs and clearly understand their responsibility and liabilities, obtain Informed Consent Forms signed voluntarily by the subjects, keep accurate and true clinical study records.Article 39: If an applicant violates GCP or requests to change the data and conclusions of clinical study, the participating institutions and personnel shall report the circumstances to PDA and SFDA. Article 40: The institutions and investigators participating in the clinical study shall be responsible for taking all necessary measures to ensure the safety of the subjects. During the clinical study the investigator shall carefully watch for the occurrence of adverse events, adopt appropriate measures, and keep a record. The institutions shall report a serious adverse event to PDA and SFDA within 24 hours of occurrence, and immediately report to the Ethics Committee.Article 41: SFDA and PDA shall conduct inspection or data audits for the approved clinical study.Article 42: SFDA may request the applicant to amend the clinical study protocol, suspend or stop the clinical study in any of the following circumstances:the Ethics Committee has failed to perform its duty。 a foreign applicant shall make application according to import drug.Article 8: A new drug application means a registration application for a drug that has not been marketed in China. A drug that has been marketed in China for which an application is made for a change in dosage form, or route of administration, add new indication shall be treated as a new drug applicationApplication for a drug already with national standards means application for production of a drug for which SFDA has already issued formal standards.Application for import drug means application for a drug produced outside China to be marketed in China.Supplemental application means an application for the change, addition, or cancellation of any item or conten