Clinical trials of thirtieth drugs (including the bioequivalence test),must be approved by the State Food and drug administration, andmust implement the "drug clinical trial quality management standards".
Pharmaceutical supervisory and administrative departments shallsupervise and inspect the clinical trial approval.
Article thirty-first apply for registration of new drugs, the clinical trial shall be conducted. Andas and supplementary application,clinical trials according to the procedures specified in the appendix.
Clinical trials are divided into I, II, III, IV.
Phase I clinical trials: clinical pharmacology and human safety evaluation and preliminary test. To observe the human body for the new drug tolerance and pharmacokinetics, dosing regimenprovides the basis for making.
Phase II clinical trials: therapeutic effect of preliminary evaluation phase. The purpose is to evaluate the therapeutic effect and safety of drugs to patients on the target, including clinical phase III study design and dosage regimen provide the basis for the determination of. The study design of this phase can according tothe specific aims of the study, using a variety of forms, including randomized controlled clinical trial.
Phase III clinical trials: treatment by stages. Its purpose is to further verify the therapeutic effect and safety of drugs to patientson the target, evaluate the relationship between interest and risk,provide a sufficient basis for the final registration application fordrug review. The test shall generally be randomized controlled trial with sufficient samples.
Phase IV clinical trials: Study on Application of new drug. The purpose is to investigate the efficacy and adverse reaction of the widely used drug conditions, the relationship between interest and risk evaluation used in ordinary or special groups and dosageetc..
Bioequivalence trial, refers to the use of biological utilization method of study, the pharmacokinetics parameters, compared with a drug of the same or different dosage form preparation, in the same experimental conditions, the human body to test itsactive ingredients absorbed degree and speed have no significant difference.
Article thirty-second drug clinical trial cases shall be in conformity with the purpose of the clinical trials and related statistical requirements, and shall not be less than the minimum clinical testcases to annex specified number. Rare disease, special diseaseconditions, required to reduce the clinical test cases or to exempt the clinical test, should be presented in applying for clinical trials,and approved by the State Food and Drug Administration review.
Article thirty-third selection stage preparation of the vaccine or other special drugs in the bacterial and virus species, there is no suitable animal models and the laboratory can not evaluate the curative effect, in order to ensure the safety of the subjects, to the State Food and Drug Administration for clinical trials.
Article thirty-fourth drug clinical trial is approved, the applicant shall choose to take drug clinical trial institution from a qualified institutions in drug clinical trials.
Drugs should be thirty-fifth clinical trials in line with the "norm" for quality control of pharmaceutical production workshoppreparation. The preparation process shall strictly implement the"norm" for quality control of pharmaceutical production requirements.
The applicant for drug clinical trial quality.
Thirty-sixth the applicant according to the clinical test its proposedby standard sample to test for use in clinical trials of drugs, drug testing can also be commissioned by the way of determining theinspection; vaccines, blood products, the State Food and Drug Administration regulations the biological products, pharmaceutical inspection shall be specified by the State Food and drug administration the test.
Clinical trials with drug testing qualified rear can be used in clinical trials.
The pharmaceutical supervisory and administrative department todrug inspection in clinical trials.
Article thirty-seventh the applicant in drug clinical trial before the implementation, shall mainly study the clinical program will have been identified and the clinical trials for the unit name, to participate in the research unit and its researchers list, ethics committee approval document, informed consent sample submit to the State Food and Drug Administration for the record, and send a copy to the clinical trials unit and the admissibility of the application of the province, autonomous region, or municipality directly under the central government and drug supervision and administration department.
Article thirty-eighth the applicant found drug clinical trial institutionviolates the relevant provisions or fails to carry out the clinical test scheme, it shall urge the rectification; if the circumstances are serious, may request the suspension or termination of the clinicaltrials, and shall report to the State Food and Drug Administrationand the relevant provinces, autonomous regions, municipalities directly under the central government, the pharmaceutical supervisory and administrative department.
Article thirty-ninth the applicant completed clinical trials, shall be submitted to the State Food and Drug Administration clinical study reports, statistical analysis report and database.
Should be implemented within 3 years after the approval offortieth drugs in clinical trials. If it is not implemented, the originalapproval documents shall be invalidated automatically; still need to conduct clinical trials, it shall re apply for the.
Serious adverse events occurred in forty-first clinical trials,researchers should report to the relevant province, autonomous region, or municipality directly under the central government and drug administration department and the State Food and drug administration, in 24 hours to inform the applicant, and promptlyreport to the ethics committee.