【文章內(nèi)容簡(jiǎn)介】 cology and human safety evaluation studies. To observe tolerance in human bodies and pharmacokinetics, providing a basis for a drug administration program.Phase II: A preliminary exploration on the therapeutic efficacy. The purpose is to evaluate the safety and efficacy of a new drug on patients within the target indication of the drugs, and providing the basis to devise Phase III Clinical Trial and to determine a drug administration program. Phase II Clinical Trial may be conducted in many ways including randomized blind controlled clinical trial in accordance with the purpose of the study.Phase III: The phase to confirm the therapeutic efficacy. The purpose is to further verify the safety and efficacy of a new drug for patients with targeted indication, to evaluate the benefit and risks relationship, and finally to provide sufficient data to support the registration approval of the drug. The trials usually are randomized, blind and controlled clinical trial with a large number of sample subjects. Phase IV: A new drug postmarketing study, conducted by the applicant. The objective is to investigate the efficacy and adverse reactions under the conditions of wide use, and to evaluate the benefit and risk relationship when used by ordinary and special groups of patients and to improve dosage of the drug.Article 25: Generally there is no need for clinical studies for the registration of a drug already with national standards. If clinical studies are needed, for a chemical drug only bioequivalence trials may be required. If the drug quality has to be controlled through the production processes and standards, clinical trials shall be conducted. For a supplemental application for a drug already marketed, clinical studies shall be conducted for an additional indication, or a significant change in the production process, or for any additional indication of TCM.Bioequivalence Trials refers to the human trials of Bioequivalence study, where statistical difference of absorption degree and speed of active ponents, in term of parameter of pharmacokinetics, will be determined by parison the same or different dosage form of the preparation at the same test conditions, Article 26: The number of cases in the clinical study of a drug should be decided in accordance with the objective of the clinical trials and shall meet both the statistical requirements and the minimal cases required by this Regulation for a clinical study. For a drug used for the treatment of rare and special diseases or other special circumstances, any reduction in the number of cases in the clinical study or exemption must be approved by SFDA. Article 27: For a vaccine and other special drugs prepared during the strains selection stage, if there is neither suitable animal experimental model nor a way to evaluate the efficacy of the drugs in laboratory study, application of clinical trials may made to SFDA, provided that safety of the subjects can be ensured.Section 2: Requirements Before ImplementationArticle 28: After approval of a clinical study, the applicant shall select qualified institutions to conduct the clinical study, negotiate and determine leading institution, principal investigator and participating institutions. Article 29: The applicant shall sign a Clinical Trial Agreement with the leading and the participating institutes selected for the clinical study, and then provide the draft Informed Consent Form and Investigator’s Brochure, jointly improve the clinical trial protocol with reference to technical guidelines. The applicant shall request the Ethics Committee of the institutions to review the clinical trial protocol.Article 30: The 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 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