Good Clinical Practice for Drug Trials

Good Clinical Practice for Drug Trials
Good Clinical Practice for Drug Trials

Order of the State Food and Drug Administration [2003] No.3

August 6, 2003

The Good Clinical Practice for Drug Trials, which was adopted upon deliberation at the executive meeting of the State Food and Drug Administration on June 4, 2003, is hereby promulgated for implementation as of September 1, 2003.

Chapter I General Provisions

Article 1 The Good Clinical Practice for Drug Trials (hereinafter referred to as the "GCP") is formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementing Regulations of the Drug Administration Law of the People's Republic of China and by reference to internationally recognized principles to ensure standard Clinical Drug Trials which will deliver scientific and reliable results, and protect the rights and interests and safety of human subjects.

Article 2 The GCP is a regulation for the standardization of the whole process of a Clinical Trial, including protocol design, organizing, conduct, monitoring, auditing, recording, analysis, summarizing and reporting.

Article 3 The GCP shall apply to all phases of a Clinical Trial, or the bioavailability trial or bioequivalence trial on the human body.

Article 4 All research involving human subjects must conform to the Declaration of Helsinki of the World Medical Association (Appendix I), namely the principles of fairness, respect of human integrity, and maximization of the benefits of and minimization of any harm to human subjects.

Chapter II Preparations and Prerequisites for Conducting a Clinical Trial

Article 5 Sufficient scientific basis must be provided for conducting Clinical Drug Trials.
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