title: Which post-marketing database and studies does EMEA require.
authors.affiliation: Federal Institute for Drugs and Medical Devices, Department Clinical Pharmacology I, Friedrich-Ebert-Allee 38, D-53113 Bonn, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Kreutz
authors.forename: L
authors.initials: L
authors.lastname: Heng
mesh_terms: D019992:Databases as Topic; D005062:European Union; D006801:Humans; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000379:methods*