注册管理办法的临床研究要求(英)

Chapter III Drug Clinical Trials Article 30 Any drug clinical trial, including bioequivalence study, shall be approved by the State Food and Drug Administration, and shall be in compliance with the Good Clinical Practice.Drug regulatory department shall supervise and inspect the approved clinical trials. Article 31 Clinical trials shall be conducted for new drug registration applications. As for generic drug registration applications and supplementary applications, clinical trials shall be conducted in accordance with the requirements in the Annex of the Provisions. A clinical trial consists of phases I, II, III and IV. Phase I Clinical Trial: initial clinical pharmacology and safety evaluation studies in humans. These studies are designed to observe tolerability of humans to and pharmacokinetics of a new drug, in order to provide basis for establishing the administration regimen. Phase II Clinical Trial: preliminary evaluation of therapeutic effectiveness of a drug. The purposes are to preliminarily evaluate the therapeutic effectiveness and safety of the drug for particular indication(s) in patients, and provide evidence for design of Phase III clinical trial and settlement of administrative dose regimen. According to specific trial objectives, this phase of trial may be designed in various forms, including the randomized blind controlled clinical trial. Phase III Clinical Trial: confirmation of therapeutic effectiveness of a drug. The purposes are to further verify drug therapeutic effectiveness and safety on eligible patients with target indication(s), to evaluate overall benefit-risk relationships of the drug, and to ultimately provide sufficient evidence for the review of drug registration application. The study, in general, shall be a randomized blind controlled trial with an adequate sample size. Phase IV Clinical Trial: a new drug post-marketing study. The purposes are to assess therapeutic effectiveness and adverse reactions when a drug is widely used, to evaluate overall benefit-risk relationships of the drug when used among general population or specific groups, and to adjust the administration dose, etc. Bioequivalence study refers to a human study, which applies bioavailability study methods with pharmacokinetic parameters as indicators to compare active ingredient absorption rate and extent of the preparations in the same or different dosage forms of a drug in terms of statistical differences under the same experimental condition. Article 32 The sample size of a drug clinical trial shall conform to the objectives of the clinical trial and fulfill statistical requirements, and shall be no smaller than the minimum number of subjects required by the Annex of the Provisions. Where there are circumstances, regarding rare or special diseases, etc., which request clinical sample size reduction or clinical trial exemption, a request shall be made with the clinical trial application, and reviewed and approved by the State Food and Drug Administration. 1 Article 33 As for vaccines prepared during bacterial or viral strain screening or other special drugs, if confirmed without any suitable animal model and laboratory measurement in terms of curative effectiveness, clinical trials may be applied for to the State Food and Drug Administration, subject to ensuring the safety of trial subjects. Article 34 When a drug clinical trial is approved, the applicant shall select institutions for the clinical trial from those certified for conducting drug clinical trials. Article 35 Drugs used for clinical trials shall be manufactured in facilities in compliance with the Good Manufacturing Practice for Pharmaceutical Products (GMP). The manufacturing process shall strictly meet the requirements of the GMP. The applicant shall be responsible for the quality of the drugs used for clinical trials. Article 36 The applicant may conduct the testing for clinical trial drugs by itself, or entrust a drug testing institute specified in the Provisions to conduct such testing, according to its proposed specifications. Vaccines, blood products and other biological products specified by the State Food and Drug Administration shall be tested by drug testing institutes designated by the State Food and Drug Administration. A drug can be used for a clinical trial only after tested as qualified. Drug regulatory departments may conduct sampling and testing on drugs used for clinical trials. Article 37 Prior to conducting a clinical trial, the applicant shall report to the State Food and Drug Administration for record while copying to the drug regulatory department of the seat of the clinical trial institution and that of the province, autonomous region or municipality directly under the Central Government to receive the application a confirmed clinical trial protocol, the name of the principal investigator at the institution in charge of the clinical trial, a list of participating institutions and names of investigators wherefrom, an ethic committee approval letter, and a template of the informed consent form, etc. Article 38 Where the applicant finds a clinical trial institution violating relevant regulations or failing to implement the clinical trial protocol, it shall urge the institution to make corrections; if the circumstances are serious, the applicant may demand suspension or termination of the clinical trial, and shall report the matter to the State Food and Drug Administration and the drug regulatory departments of the relevant provinces, autonomous regions or municipalities directly under the Central Government. Article 39 After completion of a clinical trial, the applicant shall submit a clinical trial final report, a statistical analysis report and its database to the State Food and Drug Administration. Article 40 A clinical trial shall be conducted within three years after approval. If overdue, the original approval documents shall be invalid. If the clinical trial is still needed, the application shall be reapplied for. Article 41 If any serious adverse event occurs during the clinical trial, the investigators shall report to the drug regulatory departments of the relevant provinces, autonomous regions or municipalities directly under the Central Government and the State Food and Drug Administration and notify the applicant within 24 hours, and report to the ethic committee in time. Article 42 In any of the following circumstances during a clinical trial, the State Food and Drug Administration may order the applicant to modify the protocol, suspend or terminate the clinical trial,: (1) the ethic committee fails to perform its duty; (2) safety of the subjects cannot be adequately ensured; (3) a serious adverse event is not reported within the specified timeline; (4) there is evidence to prove that the drug used for the clinical trial is not effective; (5) a quality problem of the drug used for the clinical trial occurs; (6) there is a fraud in the clinical trial; or (7) there is any other case violating the Good Clinical Practice. Article 43 Where there is any large-scale of and unexpected adverse reaction or serious adverse event, or there is evidence to prove any serious quality problem of the drug used for a clinical trial, the State Food and Drug Administration or the drug regulatory department of the province, autonomous region or municipality directly under the Central Government may take emergency control measures and order to suspend or terminate the clinical trial. The applicant and clinical trial institution must stop the clinical trial immediately. Article 44 An overseas applicant intending to conduct an international multi-center clinical trial in China shall submit an application to the State Food and Drug Administration in accordance with the Provisions, and fulfill the following requirements: (1) the drugs used for clinical trials shall be already approved or in phase II or III clinical trial overseas. The State Food and Drug Administration does not accept any overseas applicant’s international multi-center clinical trial application for any preventive vaccine not being registered overseas yet; (2) while approving to conduct an international multi-center clinical trial, the State Food and Drug Administration may require the applicant to conduct phase I clinical trial first in China; (3) when conducting an international multi-center clinical trial in China, if there are any observed serious adverse reaction and unexpected adverse reaction associated with the drug in any country, the applicant shall, in accordance with relevant regulations, report to the State Food and Drug Administration in time; (4) the applicant shall submit a complete clinical trial report to the State Food and Drug Administration after the completion of a clinical trial; and (5) the data obtained from an international multi-center clinical trial for drug registration application in China shall be in conformity with the requirements on clinical trial in the Provisions. All the study materials of the international multi-center clinical trial shall be submitted.