title: Participation of industry experts in the elaboration of monographs and chapters of the European Pharmacopoeia.
abstract: The European Pharmacopoeia represents an important element in the European regulatory system for medicines. It is elaborated in a co-operation of experts from authorities, academia and industry, assisted by scientific staff from the European Directorate for the Quality of Medicines & HealthCare (EDQM). This article describes the principles of its elaboration with particular focus on the involvement of industry experts.
authors.affiliation: European Pharmacopoeia Department, EDQM, Council of Europe, F-67081 Strasbourg, France.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Rose
mesh_terms: D004345:Drug Industry; D005060:Europe; D006801:Humans; D007391:International Cooperation; D010602:Pharmacopoeias as Topic
keywords: EDQM; European Pharmacopoeia; Groups of experts; Harmonisation of standards; Regulatory system for medicines