Requirements for quality documentation concerning biological investigational medicinal products in clinical trials

This guidance addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of investigational medicinal product (IMP) containing biological/biotechnology derived substances. It applies to cases where no 'simplified IMP Dossier' is submitted.

Please note that requirements related to the Clinical Trial Regulation will apply only on entry into application of the Regulation. Scientific requirements apply from 26 April 2018.

Keywords: Biological product, investigational medicinal product (IMP), clinical trial, quality

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