title: [Clinical trials in Germany and in the EU in the new legislative environment. An analysis from the industry's point of view].
abstract: The European Union's (EU) Directive 2001/20/EC and its accompanying directives and guidance aim at approximating laws, regulations and administrative provisions relating to the implementation of Good Clinical Practice and Good Manufacturing Practice in the conduct of clinical trials on investigational medicinal products for human use in the EU member states. In addition, the establishment of two European databases for collecting information on clinical trials and suspected unexpected serious adverse events, respectively, should increase the transparency of clinical trials in the EU and thus improve patient safety. Some member states have not implemented the EU directive yet, others have implemented modified requirements, i.e. the pharmaceutical industry in the EU is confronted with different national solutions for specific aspects of the conduct of clinical trials. For industry, this creates additional work and expense. There is the hope that patient safety will be improved by these measures. The future task of all involved stakeholders will be to work on a harmonisation of the different requirements in order to achieve the original goals intended by the Directive 2001/20/EC.
authors.affiliation: Novartis Pharma AG, Basel. karin.heidenreich@pharma.novartis.com
authors.forename: K
authors.initials: K
authors.lastname: Heidenreich
authors.forename: A
authors.initials: A
authors.lastname: Möritz
authors.forename: H
authors.initials: H
authors.lastname: Löffler
authors.forename: B
authors.initials: B
authors.lastname: Oberle-Rolle
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D005858:Germany; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence