SFDA-GCP(EN).docVIP

Good Clinical Practice [SFDA order No. 3, Effective on September 1, 2003]Chapter 1: General ProvisionsArticle 1: This Good Clinical Practice of Pharmaceutical Products (hereinafter “GCP”) is promulgated in accordance with the Drug Administration Law of PRC and Implementing Regulation of Drug Administration Law of PRC, making reference to internationally recognized principles to ensure the standardization of clinical trials of drugs which will result in scientific reliability, and the protection of the rights, benefits and safety of the human subject. Article 2: This GCP is a regulation for the standardization of the whole process of a clinical trial, including protocol designing, organizing, conducting, monitoring, auditing, recording, analyzing, summarizing and reporting. Article 3: This GCP is to be observed in all phases of a clinical trial, 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 World Medical Association (Appendix 1) i.e. fairness, respect of human integrity, maximize the benefits and minimize any harm to the human subject. Chapter 2: Preparations and Prerequisites for Conducting a Clinical TrialArticle 5: Sufficient scientific basis must be provided for conducting clinical trials of drugs. The purpose of a clinical trial, the problems to be solved, must be considered thoroughly before conducting a trial on human subjects. The anticipated benefits and risks for the human subjects and public health must be balanced. The anticipated benefits must exceed the possible harm. The selection of clinical trial methods must conform to scientific and ethical criteria.Article 6: The drugs to be used in a clinical trial shall be prepared and supplied by the sponsor. Before conducting a clinical trial, the sponsor must provide the pre-clinical study documents of the investigational product, including