title: Safety of biotechnological products.
abstract: The safety of biotechnological products used for medicinal products is addressed by EU council directives. The general principles and the regulatory framework for the handling of new drug applications within this areas are described both with respect to benefit/risk evaluation, quality assessment, preclinical safety and efficacy testing.
authors.affiliation: European Medicines Evaluation Agency, Unit for the Evaluation of Medicinal Products for Human Use, Canary Wharf, London, UK.
authors.forename: R
authors.initials: R
authors.lastname: Bass
authors.forename: J
authors.initials: J
authors.lastname: Purves
authors.forename: M P
authors.initials: MP
authors.lastname: Amati
mesh_terms: D000818:Animals; D001709:Biotechnology / Q000458:organization & administration*; D017277:Drug Approval; D005062:European Union; D006801:Humans; D018570:Risk Assessment