【正文】 g 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。D data and other data generated by the original applicant for submission of application of manufacturing or marketing of a drug containing new chemical ingredients unless the submitted data is generated by the subsequent applicant itself.Chapter 3: Preclinical Laboratory Study of DrugsArticle 15: The scope of preclinical laboratory study (preclinical study) of a drug for registration includes synthetic process, extraction methods, physicalchemical properties and purity, dosage form selection, screening of formulas, preparation process, inspection methods, specification, stability, pharmacology, toxicology and pharmacokinetic study. For TCM preparations, information such as the source and the processing of raw materials should also be included. For biological products, information such as specification, storage condition, genetic stability and immunology study of strain, cell strain as well as biological tissue should also be included.Article 16: Preclinical study of a drug shall be conducted in accordance with relevant regulations。 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 legal overseas registration shall be attached. Only after the documents are authenticated by SFDA may they be included in the registration documents. SFDA may send people to conduct onsite inspections, if necessary.Article 21: When there is a need to audit and inspect drug studies, SFDA and PDA may request the applicant or the drug research institute which conducted the experiments to repeat an experiment for any items by using the methods and data listed in the application dossier, and SFDA and PDA may send people to conduct onsite inspections of the experiment process. SFDA may also designate other drug control institutes or drug research institutions to repeat the experiments. Article 22: The preclinical study of drugs shall be conducted in accordance with relevant technical guidelines issued by SFDA. If the applicant conducts the experiments according to other methods and techniques, the applicant shall provide information to evidence that the methods and techniques are scientific. Chapter 4: Clinical Study of DrugsSection 1: Basic RequirementsArticle 23: Clinical study of drugs includes clinical trials and bioequivalence trials. Only after approval from SFDA may a clinical trial study be conducted, and it shall be conducted in accordance with Good Clinical Practice (GCP).Article 24: Clinical trials shall be conducted for the registration of a new drug.Clinical trials are divided into Phase I, Phase II, Phase III and Phase IV. Clinical trials of Phase I, Phase II and Phase III are needed for a new drug application. In some cases only Phase II and Phase III clinical trials or, only Phase III clinical