title: [Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].
abstract: In Germany, Directive 2001/20/EC is implemented by articles 40 to 42a of the Federal Drug Act and by the Decree on Good Clinical Practice. Pivotal provisions have been included into the Federal Drug Act, such as those aiming at the clinical trial subject's protection and defining responsibilities for the evaluation of applications as well as for pharmacovigilance and surveillance. The Decree comprises: relevant definitions; requirements for manufacturing, importation and labelling of investigational medicinal products; the procedures to obtain the ethics committee's opinion and the authorization from the competent authority on the trial application and on amendments thereof; documentation and information tasks of the investigator, sponsor and competent authority; rules for inspection to verify compliance with good clinical and manufacturing practice. Finally, the decree lists infringements within the meaning of article 97, paragraph 2, no. 31 of the Federal Drug Act, and lays down the necessary provisions for a transitional period and the entering into force of the new provisions.
authors.affiliation: Bundesministerium für Gesundheit und Soziale Sicherung, Bonn. walter.schwerdtfeger@bmgs.bund.de
authors.forename: W K
authors.initials: WK
authors.lastname: Schwerdtfeger
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017041:Ethics Committees / 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; D018579:Patient Selection; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence*