Quality requirements for investigational medicinal products. The state authorities' point of view

The relevant authorities must assess the quality of investigational medicinal products based mainly on the parameters "safety of the persons subject to a clinical study", "adequate reproduction of the drug model defined in the clinical trial authorization", and "reliability of documentation". Of these, the safety of the people subject to a clinical study is of predominant importance. As a consequence, this is the main focus of the authorities. Reliability and integrity of the documentation on investigational medicinal products are important for the assessment of a manufacturing license application. Therefore, this is also subject to the relevant authorities.

Published by Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2005. The guideline itself is at the source linked here.

doi.org/10.1007/s00103-004-0975-4