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Guideline for Ethical Review of Drug Clinical Trials issued
- Publisher：
- Publication：2010/11/11
In order to strengthen the quality management of drug clinical trails and the protection of research participants, standardize and instruct the ethical review of Ethics Committee in drug clinical trials, improve the quality of ethical review of drug clinical trails, the State Food and Drug Administration (SFDA) formulated the Guideline for Ethical Review of Drug Clinical Trials in accordance with the Provisions for Drug Registration and the Good Clinical Practice (GCP). The Guideline, which comprises 52 articles, was issued on November 2, 2010 and went into effect as of the date of promulgation.
source: SFDA
source: SFDA