This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

European Medicines Agency-Food and Drug Administration pilot programme for parallel assessment of quality-by-design applications: lessons learnt and questions and answers resulting from the first parallel assessment; ICH-endorsed guide for ICH Q8/Q9/Q10 implementation; Questions and answers on design-space verification Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. Recommended by The Wall Street Journal Last updated on 09.12.2016 Guidance Issuing Office.

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