title: [Clinical trials for medicinal products. New European and national legal rules].
abstract: With the 12th Amendment of the German Drug Law, in addition to other changes, transformation requirements resulting from the Directive 2001/20/EU of the European Parliament and the Council on clinical trials for medicinal products for humans have been fulfilled. Resulting changes in this context for competent federal authorities and other institutions involved are briefly presented and their relevance discussed. These new legal regulations provide a number of opportunities to plan clinical trials more effectively and to perform them in a more structured and better harmonized way, thus leading to increased safety for patients and more reliable results.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn. g.kreutz@bfarm.de
authors.forename: G
authors.initials: G
authors.lastname: Kreutz
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005062:European Union; D005858:Germany; D006801:Humans; D007880:Legislation, Drug; D012449:Safety