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[Quality requirements for investigational medicinal products. The state authorities' point of view]
1Bezirksregierung, Köln. joerg.neuhaus@berzreg-koeln.nrw.de
Abstract:
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.
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