title: [Official experimental testing of biomedical products. Regulatory frame and importance of for quality, safety and efficacy].
abstract: The official experimental testing of biomedicinal products provides a very significant contribution to ensuring quality, safety and efficacy of these indispensable medicines. Already in the prelicensing phase or to elucidate clusters of increased adverse effects, official medicinal control laboratories are committed to perform experimental testing. The official batch release can be seen as external quality control of the manufacturer's release testing. For proficient performance in these tasks, scientific research is required, in particular on the development and refinement of test methods, and considering the continuous development of innovative biomedicinal products. This article is aimed at introducing the present thematic issue and in particular the regulatory basis of experimental product testing, and illustrates by means of several examples its great importance for the sake of the patients.
authors.affiliation: Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland, Stefan.vieths@pei.de.
authors.forename: S
authors.initials: S
authors.lastname: Vieths
authors.forename: R
authors.initials: R
authors.lastname: Seitz
mesh_terms: D001688:Biological Products / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004340:Drug Contamination / Q000331:legislation & jurisprudence; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005858:Germany; D007753:Laboratories / Q000331:legislation & jurisprudence; D007880:Legislation, Drug / Q000458:organization & administration*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*; D017751:Safety Management / Q000331:legislation & jurisprudence
chemical_list: D001688:Biological Products