title: Regulatory pathways in the European Union.
abstract: In principle, there are three defined procedures to obtain approval for a medicinal product in the European Union. As discussed in this overview of the procedures, the decision on which regulatory pathway to use will depend on the nature of the active substance, the target indication(s), the history of product and/or the marketing strategy.
authors.affiliation: Pharmatching GmbH, Freiburg, Germany. manuela.kohler@pharmatching.com
authors.forename: Manuela
authors.initials: M
authors.lastname: Kohler
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods* / Q000458:organization & administration; D005062:European Union; D006801:Humans; D007880:Legislation, Drug / Q000458:organization & administration / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations