title: International specification setting--EP perspectives. European Pharmacopoeia.
abstract: The regulatory framework for medicines in Europe is outlined and the role and policies of the European Pharmacopoeia in setting requirements for biotechnology products are discussed.
authors.affiliation: National Institute for Biological Standards and Control, Potters Bar, Herts, UK. dcalam@nibsc.ac.uk
authors.forename: D H
authors.initials: DH
authors.lastname: Calam
mesh_terms: D001709:Biotechnology; D005060:Europe; D010602:Pharmacopoeias as Topic / Q000592:standards*; D011640:Public Policy