Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Scientific guideline

This guidance addresses the documentation on the chemical and pharmaceutical quality of investigational medicinal product dossier containing chemically defined drug substances, synthetic peptides, herbal substances, herbal preparations and chemically defined radio-active/radio-labelled substances to be submitted to the competent authority for approval prior to beginning a clinical trial in humans.

Please note that requirements related to the Clinical Trial Regulation will apply only on entry into application of the Regulation. Scientific requirements apply from 28 May 2018.

Keywords: Clinical trial, quality