Legal analysis: The purpose of this regulation is to ensure that the clinical trial process of drugs is standardized, the results are scientific and reliable, and the rights and interests of subjects are protected and their safety is guaranteed. Scope of application: GCP is the standard regulation of the whole process of clinical trials, which is applicable to all stages of clinical trials, human bioavailability or bioequivalence trials, including scheme design, organization and implementation, supervision, inspection, recording, analysis, summary and reporting. The basic principle of clinical trial scheme: it must conform to the Helsinki Declaration of the World Medical Congress (20 13 edition), which constitutes the basis of GCP today, that is, fairness, respect for personality, striving to maximize the interests of subjects, avoiding injuries as much as possible, and putting the interests of subjects first. GCP and other relevant laws and regulations must be observed. Must meet the requirements of science and ethics. (Ethical requirements mainly refer to that the trial scheme is approved by the ethics committee, and the subjects sign the informed consent before participating in the clinical trial). At present, this provision has expired.
Legal basis: Article 7 of the Quality Management Standard for Clinical Trials of Medical Devices issued by China Food and Drug Administration stipulates that before the clinical trial, the applicant shall complete the preclinical research of experimental medical devices, including product design (structure, working principle and mechanism, expected use, applicable scope and applicable technical requirements), quality inspection, animal test and risk analysis, and the results shall be able to support the clinical trial. The quality inspection results include the self-inspection report and product registration inspection report issued by qualified inspection institutions within one year.