title: [Harmonisation of regulatory requirements for clinical trials on medicinal products for human use in the Directive 2001/20/EC and complementary guidance. Implementation of the 12th Law Amending the German Drug Law].
abstract: Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 aims to harmonise national regulations governing clinical trials of medicinal products for human use in the European Union. This aim is to be achieved by harmonising the legal regulations and administrative provisions in force in the Member States, especially with respect to the requirements for starting and conducting clinical trials, taking into account international ethical and scientific standards (Good Clinical Practice). The goal is to further improve the protection of participants in clinical trials and to promote clinical research within the European Union. In Germany, the necessary transposition into the national Drug Law has taken place in the form of the 12th Law Amending the Drug Law of 30 July 2004 as well as complementary implementation provisions. The amendments to the German Drug Law affect in particular the official authorisation procedure, the involvement of ethics committees as well as the conduct of clinical trials on minors. The Directive's requirements have been transposed into German law while maintaining the high level of protection for the participants in clinical trials which had already existed in German legislation.
authors.affiliation: Bundesministerium für Gesundheit und Soziale Sicherung, Bonn.
authors.forename: I
authors.initials: I
authors.lastname: Geisler
authors.forename: H-P
authors.initials: HP
authors.lastname: Hofmann
authors.forename: L
authors.initials: L
authors.lastname: Nickel
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D002648:Child; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D005060:Europe; D005062:European Union; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007391:International Cooperation; D007880:Legislation, Drug / Q000592:standards*; D033242:Minors / Q000331:legislation & jurisprudence; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence