China's "Drug Administration Law" provisions of Article 102: drugs, is used for the prevention, treatment and diagnosis of human diseases, to regulate the physiological function of the human and provisions have to adapt to the disease or functional indications, usage and dosage of material, including medicines, important pieces, and medicine, chemical drug substances and preparations, antibiotics, biochemical drugs, radioactive drugs, serum, vaccines, blood products and diagnostic medicine etc..
Drug clinical trial is refers to in the body of drug effects on a series of clinical and experimental research, has been confirmed or explain the curative effect and adverse reaction of the drug test, its purpose is to determine the safety and efficacy of the drug test. Clinical trials is the research and development of new drugs del necessary stage, on the efficacy and safety of the new drug evaluation plays an irreplaceable role, the research data and the outcome of the pharmaceutical supervisory and administrative departments in the approval of new drugs important content and key basis.
Based on, China Department of Health issued by the drug clinical trial quality management standards "is formulated by the national drug supervision and Administration Department of the regulation of drug clinical trials of legal norms, for drug clinical trials in China has symbolic significance. Provisions include design, organization, implementation, supervision, inspection, record, analysis, summary and report standard. With the development of medical science and technology in our country, more and more attention has been paid to the clinical trials of drugs.
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