title: [Simplification of procedures for clinical drug trials in the EU is coming up].
abstract: A proposal for a new regulation on clinical trials that will replace the Clinical Trials Directive has been launched by the EU Commission the 17 July 2012. The proposal contains ideas that undoubtedly will lead to a greater harmonisation within the EU, a more smooth approval procedure, and a lowering of the administrative burden. Details are still to be discussed, and waiting until 2016 when the new rules are adopted is definitely a problem, but all together the new proposal is to be regarded as good news for clinical drug research.
authors.affiliation: Sektion for Samfundsfarmaci og Klinisk Farmaci, Det Sundhedsvidenskabelige Fakultet, Københavns Universitet, Universitetsparken 2, 2100 København Ø. karin@friisbach.dk
authors.forename: Karin Friis
authors.initials: KF
authors.lastname: Bach
authors.forename: Annette
authors.initials: A
authors.lastname: Jørgensen
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D005062:European Union; D006801:Humans