【正文】 he applicant shall provide the institutions with the investigational drugs and parator drugs (expect for Phase IV clinical trials) together with COA of drug samples, at no charge. The applicant shall bear the costs related to conducting the clinical study. Article 31: The investigational drugs shall be produced in a workshop which meets GMP requirements and the production process shall be strictly in accordance with the requirements of GMP.SFDA or the authorized PDA may conduct onsite audit, as necessary.Article 32: The applicant may inspect the investigational drug itself in accordance with the drug39。s approval, SFDA shall not approve a subsequent application that used, without the express consent of the original applicant, the undisclosed Ramp。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。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shall withdraw the application, and reapply according to the original application procedures.Article 59: For those withdrawn or returned application, after further studies, if the requirements of the Regulation are met and there is no new drug of the same kind enter into monitoring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。quality problems in the drug used for clinical trials。 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。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。evidence that the investigative drug is not effectiv