Healthy Skepticism Library item: 3798

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Neuhaus J.
[Quality requirements for investigational medicinal products. The state authorities' point of view]
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2005 Feb 01; 48:(2):189-95
http://scienceserver.cilea.it/cgi-bin/sciserv.pl?collection=journals&issn=14369990&volume=48&issue=2&firstpage=189

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.

Keywords:
Clinical Trials/legislation & jurisprudence* Drug Compounding/standards Drug Industry/standards Drugs, Investigational/standards* English Abstract Europe European Union* Germany International Cooperation* Quality Assurance, Health Care/legislation & jurisprudence*