【正文】 facture processing, indication etc. the applicant shall submit documents explaining the China patent status and ownership rights. If other party holds patent in China, the applicant shall submit a letter of guarantee stating that the drug will not infringe on the patent rights of others and that the applicant assumes liability for any possible infringement. Article 12: If an infringement dispute occurs after pletion of registration, the parties shall try to negotiate a resolution, or resolve the matter according to relevant laws, regulations, or rules through judicial organs or patent administration institutions. Once there is a final rule from the Patent Administration or an enforcement judgment from People’ Court to determine the fact of infringement, Patent holder may apply at SFDA for cancellation of drug approval number of infringing party. SFDA shall based on the facts, cancel the certified drug approval of infringing party. Article 13: For a drug that has obtained patent protection in China, another applicant may apply for registration within two years prior to the patent expiration. SFDA shall review the application according to this Regulation and, after expiration of the patent, approve production or import for an application that meets requirements. Article 14: For a period of 6 years from the date of the original applicant39。s approval, SFDA shall not approve a subsequent application that used, without the express consent of the original applicant, the undisclosed Ramp。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。the clinical study progress report was not timely submitted, the pletion of the clinical study is more than 2 years behind the original pletion date and there are still no results which can be evaluated。other circumstances violating GCP.Article 43: The applicant or institutions shall implement the decision regarding amendment of the clinical study protocol, or suspension or cessation of the clinical study made by SFDAArticle 44: During the clinical study, in case a large range or unexpected adverse reaction or serious adverse event occurs, or there is evidence to prove that the investigational drug has significant quality problems, SFDA or PDA may adopt emergency mandatory administrative measures to suspend or stop the clinical study, and the applicant and institutions must immediately stop the study.Article 45: The investigators shall be responsible for use of