title: [Quality requirements for investigational medicinal products. The state authorities' point of view].
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.
authors.affiliation: Bezirksregierung, Köln. joerg.neuhaus@berzreg-koeln.nrw.de
authors.forename: J
authors.initials: J
authors.lastname: Neuhaus
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004339:Drug Compounding / Q000592:standards; D004345:Drug Industry / Q000592:standards; D015507:Drugs, Investigational / Q000592:standards*; D005060:Europe; D005062:European Union; D005858:Germany; D007391:International Cooperation; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*
chemical_list: D015507:Drugs, Investigational